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
Scaler, Ultrasonic ELC
Chair, Dental, Without Operative Unit NRU
Handpiece, Direct Drive, Ac-Powered EKX
Unit, Operative Dental EIA
Plugger, Root Canal, Endodontic EKR
Motor, Surgical Instrument, Ac-Powered GEY
Dam, Rubber EIE
Handpiece, Contra- And Right-Angle Attachment, Dental EGS
Gutta-Percha EKM
Light, Operating, Dental EAZ
Frame, Rubber Dam EJE
Handpiece, Water-Powered EKY
Controller, Foot, Handpiece And Cord EBW
Forceps, Rubber Dam Clamp EJG
Handle, Instrument, Dental EJB
Handpiece, Air-Powered, Dental EFB
Syringe, Cartridge EJI
Clamp, Rubber Dam EEF
Tray, Surgical, Instrument FSM
Wire, Orthodontic DZC
Instruments, Dental Hand DZN

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