FDA Registration
Active
🇺🇸 United States
ASEPTICO, INC.
Reg #: 3017604
·
FEI: 3017604
·
Expires 2026
Products
21
Proprietary Names
418
Establishment Types
5
Classifications
21
Registration Details
- Registration Name
- ASEPTICO, INC.
- Registration Number
- 3017604
- FEI Number
- 3017604
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- Yes
- Address
- 8333 216th St SE
- City
- WOODINVILLE
- State
- WA
- ZIP
- 98072
- Country
- US
Regulatory Submissions
- 510(k) Number
- K130693
Owner / Operator
- Firm Name
- ASEPTICO, INC.
- Operator Number
- 3017604
- Address
- 8333 216TH ST., S.E., --
- City
- Woodinville
- State
- WA
- Postal Code
- 98072
- Country
- US
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Scaler, Ultrasonic | ELC | Class 2 | Dental | No | 2019-09-06 |
| Chair, Dental, Without Operative Unit | NRU | Class 1 | Dental | No | 2008-12-09 |
| Handpiece, Direct Drive, Ac-Powered | EKX | Class 1 | Dental | No | 2016-04-12 |
| Unit, Operative Dental | EIA | Class 1 | Dental | No | 2016-04-12 |
| Plugger, Root Canal, Endodontic | EKR | Class 1 | Dental | No | 2013-08-12 |
| Motor, Surgical Instrument, Ac-Powered | GEY | Class 1 | General, Plastic Surgery | No | 2015-03-11 |
| Dam, Rubber | EIE | Class 1 | Dental | No | 2007-11-06 |
| Handpiece, Contra- And Right-Angle Attachment, Dental | EGS | Class 1 | Dental | No | 2013-08-12 |
| Gutta-Percha | EKM | Class 1 | Dental | No | 2004-10-21 |
| Light, Operating, Dental | EAZ | Class 1 | Dental | No | 2002-10-16 |
| Frame, Rubber Dam | EJE | Class 1 | Dental | No | 2019-07-24 |
| Handpiece, Water-Powered | EKY | Class 1 | Dental | No | 2026-03-24 |
| Controller, Foot, Handpiece And Cord | EBW | Class 1 | Dental | No | 2026-03-05 |
| Forceps, Rubber Dam Clamp | EJG | Class 1 | Dental | No | 2019-07-23 |
| Handle, Instrument, Dental | EJB | Class 1 | Dental | No | 2004-11-16 |
| Handpiece, Air-Powered, Dental | EFB | Class 1 | Dental | No | 2021-03-15 |
| Syringe, Cartridge | EJI | Class 2 | Dental | No | 2022-05-09 |
| Clamp, Rubber Dam | EEF | Class 1 | Dental | No | 2019-07-23 |
| Tray, Surgical, Instrument | FSM | Class 1 | General, Plastic Surgery | No | 2026-04-08 |
| Wire, Orthodontic | DZC | Class 1 | Dental | No | 2019-07-23 |
| Instruments, Dental Hand | DZN | Class 1 | Dental | No | 2019-09-09 |
Proprietary Names
AEU-525CFH - TRANSPORT III WITH HANDPIECES MILITARY 110/220V DUAL VOLTAGE
AEU-350S-W
AEU-525CF Transport III Command Field Dual Voltage
AEU-525S - TRANSPORT III W/SCALER DUAL VOLT UNIT 110/220V
AEU-350-W
AEU-350S - ASEPTICO GO ULTRA PORTABLE DENTAL SYSTEM W/Scaler
AEU-525CFH-14 - TRANSPORT III WITH HANDPIECES and TIPS MILITARY 110/220V DUAL VOLTAGE
AEU-525FO - TRANSPORT III W/FIBER OPTICS DUAL VOLT PORTABLE UNIT
AEU-525CF - TRANSPORT III COMMAND FIELD DUAL VOLTAGE UNIT 110/220V
AEU-350 - ASEPTICO GO ULTRA PORTABLE DENTAL SYSTEM
AEU-525 - TRANSPORT III PORTABLE DUAL VOLT UNIT 110/220V
ADC-02 - ADVANCED PORTABLE CHAIR
ADC-10 - ADVANCED PORTABLE OPERATOR STOOL
ADC-08 - ASEPTISTOOL PORTABLE OPERATOR STOOL
ADC-01 -ASEPTICHAIR WITH CASE
ADC-01-RED - ASEPTICHAIR RED WITH CASE
ADC-01CS -ASEPTICHAIR WITH CASE
ADC-08-RED - ASEPTISTOOL PORTABLE OPERATOR STOOL - RED
ADC-09CF - COMMAND FIELD ADVANCED MIL OPERATOR STOOLS
ADC-01-BLU - ASEPTICHAIR BLUE WITH CASE
ADC-10-BLU - ADVANCED PORTABLE OPERATOR STOOL BLUE
ADC-08CF - COMMAND FIELD PORTABLE OPERATOR STOOLS 6520-01-456-5406
ADC-08S - ASEPTISTOOL MILITARY SINGLE SOFT CASE NSN 6520-01-456-5467
ADC-09S - COMMAND FIELD ADVANCED MIL OPERATOR STOOL SOFT CASE
ADC-10-RED - ASEPTISTOOL RED PORTABLE OPERATOR STOOL
ADC-02CF - MILITARY PORTABLE CHAIR
ADC-01P-RED - ASEPTICHAIR RED PEDO WITH CASE
ADC-02-BLU - ADVANCED PORTABLE CHAIR BLUE
ADC-08-BLU - ASEPTISTOOL PORTABLE OPERATOR STOOL BLUE
AEU-525 FAMILY
A115000000000 - Calamus thermal response
B00GSIQ100LRG - Gutta-Smart Electric Heat Plugger, Large
BSPGSIQ000003 - Gutta-Smart Charger Feet
A130000000033 - Calamus Dual
A120900000000 - Calamus Hand Piece Heat Shield
BCPGSIQ000BET - Gutta-Smart Cannula Bender
A130000000000 - Calamus Dual
A130000000002 - Calamus Dual
A130000000026 - Calamus Dual
B00GSIQ100000 - Gutta-Smart Thermal Response Tip
BSPGSIQ000002 - Gutta-Smart Charger top with LCD
BCPGSIQ000FLO - Gutta-Smart Flow Handpiece
A130000000022 - Calamus Dual
A120600000000 - Replacement Cartridge Nut
A113000000000 - Calamus Heated Plugger - Large
A122000000000 - Calamus Dual Gutta-Percha Cartridges 23G
A120700000000 - Cartridge Needle Bending Tool
B00GSIQ100MED - Gutta-Smart Electric Heat Plugger, Medium
BCPGSIQ000HES - Gutta-Smart Flow Heater
A120800000000 - Calamus Dual Hand Piece Cleaning Brush
B00GSIQ100SML - Gutta-Smart Electric Heat Plugger, Small
A112000000000 - Calamus Heated Plugger - Medium
BNSGSIQA0020G - Gutta-Smart GP Crtg 20G 10-pack
A111000000000 - Calamus Heated Plugger - Small
B00GSIQ000KIT - Gutta-Smart Cordless Obturation System
BSPGSIQ000001 - Gutta-Smart Charger Base
BCPGSIQ000PAK - Gutta Smart Pack Handpiece
BSPGSIQ000004 - Fastener screw
BCPGSIQ000RPC - Gutta-Smart Remote Power Cord
BNSGSIQA0023G - Gutta-Smart GP Crtg 23G 10-pack
B00GSIQ000BAS - Gutta-Smart Base Station
BNSGSIQA0025G - Gutta-Smart GP Crtg 25G 10-pack
A121000000000 - Calamus Dual Gutta-Percha Cartridges 20G
BCPGSIQ000CAP - Gutta-Smart Cleaning Caps
AE-24DIS - TUBING SET DISPOSABLE 10 FT AEU-1000/1070 (Single)
FUE-100
AEU-1070TRE-70V
AE-24DIS-10 - TUBING SET DISPOSABLE 10 FT AEU-1000/1070 (PKG 10)
I-70BM - HANDIDAM W/PLASTIC FRAME BLUE PKG OF 20
I-70BM-100 - HANDIDAM ASEPTICO MED BLUE-100 PKG OF 100
I-70K - CLAMP KIT HANDIDAM
I-70LF-100 - HANDIDAM-LF LATEX FREE RUBBER DAM MAUVE PKG OF 100
I-70LF - HANDIDAM-LF LATEX FREE RUBBER DAM MAUVE PKG OF 20
AEU-7000L-70V-W --IMPLANT SURGERY SYSTEM ENDO W/ LIGHT AND VARIABLE WIRELESS FOOTSWITCH
AEU-7000E-70V-W -- IMPLANT SURGERY SYSTEM ENDO W/ VARIABLE WIRELESS FOOTSWITCH
AEU-27DTCR -- ENDODONTIC SYSTEM AEU-27DTCR
AEU-7000L-W -- IMPLANT SURGERY SYSTEM ENDO W/ LIGHT ON/OFF AND WIRELESS FOOTSWITCH
ENDODONTIC SYSTEM AEU-27DTCR W/ ON/OFF WIRELESS FOOTSWITCH
AEU-28SYB
AEU-1070 - IMPLANT SURGERY SYSTEM TOUCH SCREEN 70NCM W/AE-7PM FOOTSWITCH
AEU-1000-OCO - IMPLANT SURGERY SYSTEM TOUCH SCREEN OCO
AEU-28KER-4 - KERR ENDODONTIC SYSTEM 065-1601 AUS CORD
AEU-6000MG - IMPLANT SURGERY UNIT MEGAGENIMPLANT
AE-70V2-10 - FOOTSWITCH VARIABLE IMPLANT V2 W/10FT CABLE
AEU-27TS - ENDODONTIC SYSTEM AEU-27TS (SCHOOL GRANT PMKEM1SPCL)
AEU-6000GLI - IMPLANT SURGERY SYSTEM GLIDEWELL
AEU-1000BSB-70V - IMPLANT SURGERY SYSTEM TOUCH SCREEN BSB W/AE-70V FOOTSWITCH
AE-70V2SWM - FOOTSWITCH VARIABLE IMPLANT V2 SWM
AE-7PM-SYB28 - FOOTSWITCH ON/OFF 4 PIN MALE 28 SYBRON
AEU-7000L-70V - IMPLANT SURGERY SYSTEM ENDO W/AE-70V AND LIGHT
AE-10 - TUBING LRG 5FT/MIN FOR AE-20 SILICONE 62ID X .125OD
AE-230L-40EXT - MOTOR/CABLE ASSY AE-230L-40EXT LED LIGHTED W/10 FT CABLE
AEU-25ITL - ENDO UNIT SWEDEN & MARTINA S.p.A.
AE-7PM-KER - FOOTSWITCH ON/OFF 4 PIN MALE 28 KERR
AEU-6000PTP-70V -IMPLANT SURGERY UNIT PALTOP W/AE-70V FOOTSWITCH
AEU-7000E-MIS-70V - IMPLANT SURGERY SYSTEM ENDO MIS W/AE-70V FOOTSWITCH
AE-70V2-GLI - FOOTSWITCH VARIABLE IMPLANT V2 GLIDEWELL
AEU-20 - ASEPTICO UNIT W/ TORQUE-110V SOLD WITH AE-4B-10
AEU-28KER-5 - KERR ENDODONTIC SYSTEM 065-1603 UK CORD
AEU-6000-70V -IMPLANT SURGERY UNIT W/AE-70V FOOTSWITCH
AEU-26MMT - MOTOR SYSTEM MMT
AE-230A-40 - MOTOR/CABLE ASSY AE-230A-40
AEU-7000E-SFI-70V - IMPLANT SURGERY SYSTEM ENDO SHATKIN W/AE-70V FOOTSWITCH
AEU-1070-70V - IMPLANT SURGERY SYSTEM TOUCH SCREEN 70NCM W/AE-70V FOOTSWITCH
AEU-1000-IVS-70V - IMPLANT SURGERY SYSTEM TOUCH SCREEN IVS W/AE-70V FOOTSWITCH
AE-70V2MG-10 - FOOTSWITCH VARIABLE IMPLANT V2 MEGAGEN W/10FT CABLE
AE-23-10 - TUBING SET 10 FT AEU-7000 BAG
AEU-6000-OCO-70V - IMPLANT SURGERY UNIT OCO BIOMEDICAL W/AE-70V FOOTSWITCH
AEU-6000SAU-70V - IMPLANT SURGERY UNIT STERNGOLD W/AE-70V FOOTSWITCH
AEU-25T - TULSA DENTAL ENDO UNIT **INCL AE-4B-30
AHP-07 - CANNULA CLIP SET
AE-225-30 -MOTOR/CABLE ASSY AE-225-30
AHP-04 - CANNULA W/NIPPLE & TUBING
AE-20Y - TUBING PUMP SET AEU-707Y YOSHIDA
AEU-5000 - OPERATIVE DENTAL SYSTEM
AEU-7000L - IMPLANT SURGERY SYSTEM ENDO W/LIGHT
AE-23-PUMP - TUBING SET PUMP SECTION
AE-7P - FOOTSWITCH ON/OFF 8 PIN
AHP-07T - TUBE EXTERNAL IRRIGATION 6.5" L 42ID X .120OD
AEU-1000 - IMPLANT SURGERY SYSTEM TOUCH SCREEN
AEU-28KER-2 - KERR ENDODONTIC SYSTEM 065-1602 EU CORD
AEU-6000SWM-110 - IMPLANT SURGERY SYSTEM SWEDEN & MARTINA (US)
AE-70V2 - FOOTSWITCH VARIABLE IMPLANT V2
AEU-6000SWM - IMPLANT SURGERY SYSTEM SWEDEN & MARTINA
AEU-7000LNE-70V - IMPLANT SURGERY SYSTEM ENDO W/AE-70V2-10 NEOCIS
AEU-6000MIS-70V - IMPLANT SURGERY UNIT MIS W/AE-70V FOOTSWITCH
AE-20 - TUBING PUMP SET ASEPTICO
AEU-28KER-6 - KERR ENDODONTIC SYSTEM 065-1605 EDU WITH N AMER CORD
AE-4B-30 - MOTOR/CABLE ASSY AE-4B 30K
AEU-6000SDI-70V - IMPLANT SURGERY UNIT SPIRALTECH W/AE-70V FOOTSWITCH
AE-70V2BSB - FOOTSWITCH VARIABLE IMPLANT V2 BLUE SKY BIO
AEU-7000E-70V - IMPLANT SURGERY SYSTEM ENDO W/AE-70V FOOTSWITCH
AEU-27A - ASEPTICO ENDODONTIC SYSTEM
AEU-1070PTP-70V - IMPLANT SURGERY SYSTEM TOUCH SCREEN 70NCM PTP W/AE-70V FOOTSWITCH
AEU-7000E-MG - IMPLANT SURGERY SYSTEM ENDO MEGAGEN
AE-7PMD - FOOTSWITCH ON/OFF DUAL 4 PIN MALE
AE-225-30MMT - MOTOR/CABLE ASSY W/EXTENDED CABLE AE-225-30MMT
AE-230L-40 - MOTOR/CABLE ASSY AE-230 LED LIGHTED
AEU-6000-IVS-70V - IMPLANT SURGERY UNIT IMPLANT VISION W/AE-70V FOOTSWITCH
AE-7PM - FOOTSWITCH ON/OFF 4 PIN MALE
AEU-6000ARM-70V -IMPLANT SURGERY UNIT ARGON MEDICAL W/AE-70V FOOTSWITCH
AEU-7000LS - IMPLANT SURGERY SYSTEM ENDO SWEDEN & MARTINA W/AE-70V AND LIGHT
AEU-26BIC - IMPLANT SYSTEM BICON
AE-230M-40 - MOTOR/CABLE ASSY AE-230M-40
AE-2MB - FTN MONT BLANC STNLS STEEL Y
AE-2 - FTN BARB 1/16 Y PLASTIC
AHP-05 - HPCE IRR/CONTRA ANGLE CLIP
AEU-6000GLI-70V - IMPLANT SURGERY SYSTEM GLIDEWELL W/AE-70V FOOTSWITCH
AEU-1000-70V - IMPLANT SURGERY SYSTEM TOUCH SCREEN W/AE-70V FOOTSWITCH
AEU-7000E - IMPLANT SURGERY SYSTEM ENDO
AE-5M1 - HOLDER HNDPCE CRADLE M1
AEU-25SSW - SSWHITE ENDO UNIT
AE-250-30 - MOTOR/CABLE ASSY AE-250-30
AEU-6000 - IMPLANT SURGERY UNIT
AE-250-KER - MOTOR/CABLE ASSY AE-250-KER
AE-70V2SFI - FOOTSWITCH VARIABLE IMPLANT V2 SFI
AHP-03 - HPCE IRR/CABLE CLIP PKG OF 10 HOLDS IRRIG TUBE TO HMTR CABLE
AEU-6000ADN-110 - IMPLANT SURGERY UNIT ADIN W/AE-70V FOOTSWITCH
AE-7PM-T - FOOTSWITCH ON/OFF 4 PIN MALE TULSA DENTAL SPECIALTIES
AE-230M-40EXT - MOTOR/CABLE ASSY AE-230M-40EXT W/10 FT CABLE
AE-250-30-T - MOTOR/CABLE ASSY AE-250-30-T
AEU-25FP-T - FIELD PROGRAMER FOR AEU-25T (AEU25PGM)
AE-250-SYB - MOTOR/CABLE ASSY AE-250-SYB
AHP-06 - HPCE BODY CLIP
AEU-25 - ASEPTICO ENDO UNIT **INCL AE-4B-30
AEU-6000ADN - IMPLANT SURGERY UNIT ADIN W/AE-70V FOOTSWITCH EURO CORD
AE-24 - TUBING SET AEU-1000 BAG
AEU-27T - ENDODONTIC SYSTEM AEU-27T
AE-250F-30 - MOTOR/CABLE ASSY AE-250F-30
AE-23-BOT - TUBING SET AEU-7000 BOTTLE
AE-240-40 - MOTOR/CABLE ASSY AE-240-40
AEU-26OS - IMPLANT SYSTEM ASEPTICO
AE-24-BOT - TUBING SET AEU-1000 BOTTLE
AE-3 - FTN BARB 1/16 CONNECTOR PLTD
AEU-28KER-1 - KERR ENDODONTIC SYSTEM 065-1600 N AMER CORD
AEU-28SYB-1 - SYBRON ENDODONTIC SYSTEM 815-1500 N AMER AND AUS
AE-7A-10 - FOOTSWITCH ON/OFF W/8PIN 10FT
AEU-6000SAU - IMPLANT SURGERY UNIT STERNGOLD
AEU-28SYB-2 - SYBRON ENDODONTIC SYSTEM 815-1502 EU AND UK
AE-23 - TUBING SET AEU-7000 BAG
AE-7PM-10 - FOOTSWITCH ON/OFF 4 PIN MALE 10 FT
AEU-7000L-MIS-70V - IMPLANT SURGERY SYSTEM ENDO MIS W/AE-70V AND LIGHT
AEU-6000PDR-70V - IMPLANT SURGERY UNIT PDR W/AE-70V FOOTSWITCH
AE-7P-10 - FOOTSWITCH ON/OFF 8 PIN - 10FT
AE-4B-10 - MOTOR/CABLE ASSY AE-4B 10K
AEU-6000GCR-70V - IMPLANT SURGERY UNIT GENICORE W/AE-70V FOOTSWITCH
AE-24-PUMP - TUBING SET PUMP SECTION AEU-1000
AEU-6000-OCO - IMPLANT SURGERY UNIT OCO BIOMEDICAL
ENDODONTIC SYSTEM AEU-27DTCR
AEU-6000-W -- IMPLANT SURGERY UNIT W/ ON/OFF WIRELESS FOOTSWITCH
AEU-1070-W -- DENTAL IMPLANT MOTOR SYSTEM 70 NCM W/ ON/OFF WIRELESS FOOTSWITCH
AEU-6000-70V-W -- IMPLANT SURGERY UNIT W/ VARIABLE WIRELESS FOOTSWITCH
AEU-7000E-W -- IMPLANT SURGERY SYSTEM ENDO W/ ON/OFF WIRELESS FOOTSWITCH
AEU-27DTCR-W -- ENDODONTIC SYSTEM AEU-27DTCR W/ ON/OFF WIRELESS FOOTSWITCH
AEU-1070-70V-W -- DENTAL IMPLANT MOTOR SYSTEM 70 NCM W/ VARIABLE WIRELESS FOOTSWITCH
AHP-101 - HPCE 1:1 STRT LOW SPEED DORIOT
AHP-53 - HPCE 1:1 DORIOT CONTRA
AHP-55 - HPCE HI-SPEED ECONOMY 4H
AHP-64 - HANDPIECE STRAIGHT 1:1 40K
AHP-85MB-X - HPCE 20:1 PUSH BTN CONTRA ANGLE MONT BLANC EVOLUTION
AHP-85MB-CX - HPCE 20:1 PB CONTRA ANGLE MONT BLANC CONTROL
AHP-88MNP - HPCE 8:1 MICRO-NITI PUSH BUTTON
AHP-63MBFO-XL - HPCE 1:1 CONTR W/FIB OPT & WATER MONT BLANC EVOLUTION
AHP-85-I - HPCE 20:1 CONTRA ANGLE LATCH IMPULSION
AHP-62MN - HPCE 16:1 MICRO-NITI CONTRA ANGLE LATCH HEAD
AHP-50 - MOTOR AIR 20K RPM 4H
AHP-65TI-FO - HPCE 1:3 INCREASER W/ WATER W/ FIB OPT
AHP-63NAK - HPCE 1:1 CONTRA LATCH ANGLE
AHP-77DS - HPCE ORAL SURGERY 1:2 NSK STRAIGHT
AHP-71TI-X - HPCE 1:5 INCREASER W/WATER
AHP-88MN - HPCE 8:1 MICRO-NITI CONTRA ANGLE LATCH HEAD
AHP-85MB-CAN - CANNULA MONT BLANC INTERNAL
AHP-85MB-CS - DEPTH STOP FOR AHP-85MB-C HANDPIECE
AHP-77D-NOZ - WATER NOZZLE AHP-77D (H265A001)
AHP-62MNP - HPCE 16:1 MICRO HEAD PUSH BUTTON
AHP-85P-I - HPCE 20:1 PUSH BUTTON CONTRA REINFORCED IMPULSION
AHP-85MB-CLP - CLIP MONT BLANC EXTERNAL
AHP-11 - ONESTEP LUBRICANT WITH E TYPE NOZZLE ADAPTER
AHP-09 - ASEPTISPRAY HPCE LUBRICANT WITH E TYPE NOZZLE ADAPTER
AHP-55T - TURBINE FOR AHP-55
AHP-82T - HPCE TORQUE HEAD K-STYLE VECTOR FIBER OPTIC HIGH SPEED
AHP-85MBFO-CX - HPCE 20:1 PUSH BTN CONTRA ANG W/FIB OPT MONT BLANC CONTROL
AHP-72C-FO - HPCE 1:5 CONTRA INCREASER SPEED W/FIBER OPT & AIR
AHP-51 - HPCE 1:1 STRAIGHT E TYPE L
AHP-56FUE - HPCE 4:1 CONTRA FUE DRIVE
AHP-85MB-STP - DEPTH STOP ONLY FOR AHP-85MB-C
AHP-65TI - HPCE 1:3 INCREASER W/ WATER
AHP-96 - HPCE CHAMP-AIR 4-HOLE PUSH BUTTON HIGHSPEED REF#AC5000-4P
AHP-97 - HPCE HIGH SPEED 5-H W/FIBER OP (135985)
AHP-64MKI - HANDPIECE STRAIGHT 1:1 40k w/ INTERNAL IRRIGATION
AHP-50MK - MOTOR AIR 4-HOLE E-TYPE 20K RPM
AHP-96MK - HANDPIECE 4-HOLE PB STD HEAD HIGHSPEED
Mont Blanc Handpieces
GP-025SP-MF - GUTTA PERCHA 25 MAILLEFER / 23G
GP-018CP-ROW - GUTTA PERCHA 18 PACKAGED CARTRIDGE FOR AEU-65-ROW
GP-025SP - GUTTA PERCHA 25 PACKAGED CARTRIDGE STANDARD FILL MATERIAL (CALG23)
GP-035CP-ROW - GUTTA PERCHA 35 PACKAGED CARTRIDGE FOR AEU-65-ROW
GP-035SP-MF - GUTTA PERCHA 35 MAILLEFER / 20G
GP-035SP-VDW - GUTTA PERCHA 35 FOR VDW PACKAGED-STANDARD FILL MATERIAL
GP-018E20P - GUTTA PERCHA 18 PACKAGED CARTRIDGE EASY FLOW MATERIAL (CALG25)
GP-018E20P-VDW - GUTTA PERCHA 18 FOR VDW PACKAGED-EASY FLOW FILL MATERIAL
GP-018CP-DS - GUTTA PERCHA 18 PACKAGED CARTRIDGE FOR AEU-65-DS
GP-025CP-DS - GUTTA PERCHA 25 PACKAGED CARTRIDGE FOR AEU-65-DS
GP-035EP - GUTTA PERCHA 35 PACKAGED ENDODENT MATERIAL (CALG202)
GP-025CP-ROW - GUTTA PERCHA 25 PACKAGED CARTRIDGE FOR AEU-65-ROW
GP-035SP - GUTTA PERCHA 35 PACKAGED CARTRIDGE STANDARD FILL MATERIAL (CALG20)
GP-025EP - GUTTA PERCHA 25 PACKAGED ENDODENT MATERIAL (CALG232)
GP-035CP-DS - GUTTA PERCHA 35 PACKAGED CARTRIDGE FOR AEU-65-DS
GP-025SP-VDW - GUTTA PERCHA 25 FOR VDW PACKAGED-STANDARD FILL MATERIAL
ALU-40LED - LIGHT PORTABLE LED OPERATORY
ALU-40LED-CF - LIGHT PORTABLE LED OPERATORY 6520-01-600-8241
ALU-40MOM - LIGHT PORTABLE LED OPERATORY W/STAND MOM
ALU-40MOM - LIGHT PORTABLE LED OPERATORY MOM
AEU-14 FAMILY
B00GS1Q100000 Gutta-Smart Thermal Reponse Tip
B00GS1Q100MED Gutta-Smart Electric Heat Plugger, Medium
B00GS1Q00LRG Gutta-Smart Electric Heat Plugger, Large
B00GS1Q100HES Gutta-Smart Heating Element
B00GS1Q100SML Gutta-Smart Electric Heat Plugger, Small
A113000000000 - Calamus Heated Plugger - Large
V040532053060 - GUTTA PERCHA-Beefill Cartridge 23G
V040532053045 - GUTTA PERCHA-Beefill Cartridge 25G
V040546000050 - Plugger root canal endodontic Beefill Heat Plugger Soft 50/5
A130000000022 - Calamus Dual - AUS
A130000000000 - Calamus Dual - EUR
A130000000026 - Calamus Dual - JAP
A130000000002 - Calamus Dual - CH
V040546000060 - Plugger root canal endodontic Beefill Heat Plugger Soft 60/6
V040532053080 - GUTTA PERCHA-Beefill Cartridge 20G
V040548000000 - Dental Hand Instrument-Beefill Thermal Response Tip
V040547000040 - Plugger root canal endodontic Beefill Heat Plugger Standard 40/3
A130000000033 - Calamus Dual - UK
V040541000000 - Dental Hand Instrument-Beefill 2in1 (Obturation Device)
I-17 - RUBBER DAM FRAME CHILD
I-16 - RUBBER DAM FRAME ADULT
AHP-85-SS Handpiece, contra-and right angle attachment, dental
BNSGS1QA0020G Gutta-Smart GP Crtg 20G 10-Pack
BNSGS1QA0023G Gutta-Smart GP Crtg 23G-10 Pack
BNSG1QA0025G Gutta-Smart GP Crtg 25G-10 Pack
V040532053060 - Beefill Guttapercha Cartridge 23G = 0,6mm
V040532053080 - Beefill Guttapercha Cartridge 20G = 0,8mm
V040532053045 - Beefill Guttapercha Cartridge 25G = 0,45mm
I-18 - PUNCH RUBBER DAM
I-15 - TEMPLATE RUBBER DAM
I-14 - FORCEP RUBBER DAM
I-19 - RUBBER DAM PUNCH (IVORY STYLE)
AEU-45 FAMILY
AHP-63MK - HANDPIECE 1:1 CONTRA LATCH = MK-Dent PN# LB11/11C BASIC LINE Contra Angle Handpiece
AHP-72MK-FO - HANDPIECE 1:5 CONTRA W/FO & WATER INCREASER = MK-Dent PN# LE15L ECO LINE Contra Angle Handpiece with Light
AHP-97MK - HANDPIECE 5-HOLE PB STD HEAD W/FO HIGHSPEED = MK-Dent PN# HE16L ECO LINE High Speed Handpiece with Light
AHP-96MK - HANDPIECE 4-HOLE PB STD HEAD HIGHSPEED = MK-Dent PN# HE17 ECO LINE High Speed Handpiece
AHP-82MK-QD - HANDPIECE KAVO 6-PIN LED FO QUICK COUPLER = MK-Dent PN# QC6016KW Quick Connector, 4 holes (6 pins)
AHP-82MK - HANDPIECE KAVO COUPLING FO STD HEAD HIGH SPEED = MK-Dent PN# HP21KL PRIME LINE High Speed Handpiece with Light
AHP-50MK - MOTOR AIR 4-HOLE E-TYPE 20K RPM = MK-Dent PN# AM0004 Airmotor, 4 holes, 2000 rpm
AEU-1070-W
AEU-20 FAMILY
AEU-707 FAMILY
AEU-17 FAMILY
AEU-7000L/7000L-70V IMPLANT SURGERY SYSTEM ENDO W/LIGHT
AEU-25 FAMILY
AEU-1070, AEU-1070-70V DENTAL IMPLANT MOTOR SYSTEM 70 NCM
AEU-1000, AEU-1000-70V DENTAL IMPLANT MOTOR SYSTEM 50 NCM
AEU-925
CAL-2118 Calaject
K-211 - RUBBER DAM CLAMP LABIAL #211
K-56A - RUBBER DAM CLAMP MOLAR #56A
K-139 - RUBBER DAM CLAMP MOLAR # 139
K-209 - RUBBER DAM CLAMP BICUSPID #209
K-51 - RUBBER DAM CLAMP MOLAR #51
K-210 - RUBBER DAM CLAMP LABIAL #210
K-90N - RUBBER DAM CLAMP LABIAL #90N
K-4 - RUBBER DAM CLAMP MOLAR #4
K-2A - RUBBER DAM CLAMP BICUSPID #2A
K-14 - RUBBER DAM CLAMP MOLAR #14
K-8A - RUBBER DAM CLAMP MOLAR #8A
K-W8A - RUBBER DAM CLAMP MOLAR #W8A
K-203 - RUBBER DAM CLAMP MOLAR #203
K-5 - RUBBER DAM CLAMP MOLAR #5
K-28 - RUBBER DAM CLAMP MOLAR #28
K-205 - RUBBER DAM CLAMP MOLAR #205
K-13A - RUBBER DAM CLAMP MOLOR #13A
K-G2 - RUBBER DAM GAUZE CLAMP #G2
K-P2 - RUBBER DAM CLAMP PEDO #P2
K-206 - RUBBER DAM CLAMP BICUSPID #206
K-29 - RUBBER DAM CLAMP BICUSPID #29
K-6 - RUBBER DAM CLAMP LABIAL #6
K-1A - RUBBER DAM CLAMP BICUSPID #1
K-W2A - RUBBER DAM CLAMP BICUSPID #W2A
K-25 - RUBBER DAM CLAMP MOLAR #25
K-2 - RUBBER DAM CLAMP BICUSPID #2
K-P1 - RUBBER DAM CLAMP PEDO #P1
K-27 - RUBBER DAM CLAMP BICUSPID #27
K-202 - RUBBER DAM CLAMP MOLAR #202
K-7 - RUBBER DAM CLAMP MOLAR #7
K-212 - RUBBER DAM CLAMP LABIAL #212
K-26 - RUBBER DAM CLAMP MOLAR #26
K-201 - RUBBER DAM CLAMP MOLAR #201
K-14A - RUBBER DAM CLAMP MOLAR #14A
K-1 - RUBBER DAM CLAMP BICUSPID #1
K-3 - RUBBER DAM CLAMP BICUSPID #3
K-8 - RUBBER DAM CLAMP MOLAR #8
K-22 - RUBBER DAM CLAMP BICUSPID #22
K-9 - RUBBER DAM CLAMP LABIAL #9
K-12A - RUBBER DAM CLAMP MOLAR #12A
K-00 - RUBBER DAM CLAMP BICUSPID #00
K-G1 - RUBBER DAM GAUZE CLAMP #G1
K-15 - RUBBER DAM CLAMP MOLAR #15
K-7A - RUBBER DAM CLAMP MOLAR #7A
K-56 - RUBBER DAM CLAMP MOLAR #56
K-208 - RUBBER DAM CLAMP BICUSPID #208
K-207 - RUBBER DAM CLAMP BICUSPID #207
K-W3 - RUBBER DAM CLAMP MOLAR W3
K-138 - RUBBER DAM CLAMP MOLAR #138
K-200 - RUBBER DAM CLAMP MOLAR #200
K-0 - RUBBER DAM CLAMP BICUSPID #0
K-18 - RUBBER DAM CLAMP MOLAR #18
AEU-7000E-W
AEU-7000L-W
AEU-7000E-70V-W
AEU-7000L-70V-W
AA-25ST - VACUUM SALIVA EJECTOR FOR USE ON ADU-04ST
AE-240SC-40 - MOTOR/CABLE ASSY AE-240SC-40 W/SHORT CABLE
AA-100-110 -COMPRESSOR AIRPAC III 110V
AA-96EXT - AIR EXTENSION LINE 25FT
ADU-07 - HPCE CONTROL MANUAL SYSTEM
AMC-25CF-USAF - MOBILE DENTAL CART AMC-25CF-USAF
ASU-12-110 - AUTOCLAVE PORTABLE PRESTIGE CLASSIC 110V
ADU-17A - EXPRESS AIR PORTABLE UNIT
ATC-03CF - COMMAND AIR PORTABLE TRAY 6520-01-446-6263
ADU-17A2 - EXPRESS AIR 2 PORTABLE UNIT
ASC-10-ACC - ACCESSORY KIT ASC-10 SCALER
ADU-25 - ENDO-CART BASE MODEL
AMC-25 - MOBILE DENTAL CART AMC-25
AA-100-220 - COMPRESSOR AIRPAC III 220V
NWS-7I - WATER SYS SELF-CONT INSTALLED NON-STERILE
ADU-17X2 - EXPRESS PLUS II PORTABLE UNIT
ADU-01C - CASE PORTABLE SUPPLY 5 DRAWER
ADU-03ST - THREE WAY AIR-WATER SYRINGE W/ STAND
NWS-8 - WATER SYSTEM
ASU-12-230 - AUTOCLAVE PORTABLE PRESTIGE CLASSIC 230V
AMC-25CF - MOBILE DENTAL CART AMC-25CF
TA-90VC - SYRINGE TA-90 VALVE CARTRIDGE
AA-525AMAL - AMALGAM SEPARATOR AEU-525 PORTABLE
TA-1 - SYRINGE TIP AUTOCLAVABLE 3-WAY
ADU-22 - PORTACART ECONOMY CART
AA-20A - AUXILIARY ARM MOBILE DENTAL CART SYSTEM AMC-20 / AMC-25
ADU-04 - TWO HPCE MINI CONTROL
ATC-12V2 - CART 4 SHELF ADJUSTABLE WITH AC POWER
AA-12HVE - ADAPTER HVE ADU-12 TASKFORCE
ADU-20B - COMPRICART II
AE-200-30 - MOTOR/CABLE ASSY W/LIGHT & H2O
ADU-07A - HPCE CONTROL AUTOMATIC SYSTEM ECONOMY
ADU-12DCE - ASEPTICO TASK FORCE DELUXE
AE-205-30EXT - MOTOR/CABLE ASSY 30K EXTERNAL WATER
ADU-04ST - TWO HPCE MINI CONTROL W/ STAND
AA-20 - VACUUM RECHARGEABLE PORTABLE
ADU-17X - EXPRESS II PORTABLE UNIT
AA-21ST - VACUUM HIGH VOLUME AVS INSTALLED ON ADU-04ST
AA-12CSB - BRKT ADU-12 CASE LID STANDOFF BRACKET KIT
ASC-10L-ACC - ACCESSORY KIT W/SLEEVE FOR LED ASC-10 SCALER
AA-26SS - COLLECTOR DRY ORAL CUP STAINLS STEEL W/ STRAINER
AMC-20 FAMILY
AMC-25 FAMILY
AMC-15 Basic Mobile Dental Cart
AEU-1070-70V-W
AEU-6000-W
AEU-6000-70V-W
AA-1070TRE-TRAY -- INSTRUMENT TRAY TREACE PERCUPLASTY MIS POWER SYSTEM
AMA-09A2 - KIT BICUSPID CHAIN / GRID
AMA-09A3 - KIT INCISOR CHAIN / GRID
AMA-09D - LINGUAL BUTTONS PKG/6
AMA-09A - KIT CUSPID CHAIN / GRID
BCPGS1Q000FLO Gutta-Smart Flow Handpiece
B00GS1Q000BAS Gutta-Smart Base Station
BCPGS1Q000PAK Gutta-Smart Pack Handpiece
B00GS1Q000KIT Gutta-Smart Kit
BCPGS1Q000BET Gutta-Smart Cannula Bender
BCPGS1Q000CAP Gutta-Smart Cleaning Caps
Establishment Types
Manufacture Device in the United States for Export Only
Complaint File Establishment per 21 CFR 820.198
Manufacture Medical Device
Manufacture Medical Device for Another Party (Contract Manufacturer)
Develop Specifications But Do Not Manufacture At This Facility