FDA Registration
Active
🇺🇸 United States
AEU-28SYB
Reg #: 3017604
·
FEI: 3017604
·
Expires 2025
Products
1
Proprietary Names
110
Establishment Types
3
Classifications
1
Registration Details
- Registration Name
- ASEPTICO, INC.
- Registration Number
- 3017604
- FEI Number
- 3017604
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- Yes
- Address
- 8333 216th St SE
- City
- WOODINVILLE
- State
- WA
- ZIP
- 98072
- Country
- US
Regulatory Submissions
- 510(k) Number
- K111078
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 |
|---|---|---|---|---|---|
| Handpiece, Direct Drive, Ac-Powered | EKX | Class 1 | Dental | No | 2011-10-31 |
Proprietary Names
AEU-28SYB
AE-7PM-T - FOOTSWITCH ON/OFF 4 PIN MALE TULSA DENTAL SPECIALTIES
AE-23 - TUBING SET AEU-7000 BAG
AE-250-30-T - MOTOR/CABLE ASSY AE-250-30-T
AE-23-10 - TUBING SET 10 FT AEU-7000 BAG
AE-230M-40EXT - MOTOR/CABLE ASSY AE-230M-40EXT W/10 FT CABLE
AEU-28KER-2 - KERR ENDODONTIC SYSTEM 065-1602 EU CORD
AE-7PM - FOOTSWITCH ON/OFF 4 PIN MALE
AHP-05 - HPCE IRR/CONTRA ANGLE CLIP
AEU-7000E - IMPLANT SURGERY SYSTEM ENDO
AE-70V2-10 - FOOTSWITCH VARIABLE IMPLANT V2 W/10FT CABLE
AEU-27TS - ENDODONTIC SYSTEM AEU-27TS (SCHOOL GRANT PMKEM1SPCL)
AE-7PM-10 - FOOTSWITCH ON/OFF 4 PIN MALE 10 FT
AEU-25FP-T - FIELD PROGRAMER FOR AEU-25T (AEU25PGM)
AEU-6000PTP-70V -IMPLANT SURGERY UNIT PALTOP W/AE-70V FOOTSWITCH
AE-250F-30 - MOTOR/CABLE ASSY AE-250F-30
AEU-20 - ASEPTICO UNIT W/ TORQUE-110V SOLD WITH AE-4B-10
AEU-7000LS - IMPLANT SURGERY SYSTEM ENDO SWEDEN & MARTINA W/AE-70V AND LIGHT
AEU-26BIC - IMPLANT SYSTEM BICON
AEU-6000-OCO - IMPLANT SURGERY UNIT OCO BIOMEDICAL
AEU-26MMT - MOTOR SYSTEM MMT
AE-230A-40 - MOTOR/CABLE ASSY AE-230A-40
AEU-6000SAU - IMPLANT SURGERY UNIT STERNGOLD
AEU-7000E-SFI-70V - IMPLANT SURGERY SYSTEM ENDO SHATKIN W/AE-70V FOOTSWITCH
AE-20Y - TUBING PUMP SET AEU-707Y YOSHIDA
AE-70V2MG-10 - FOOTSWITCH VARIABLE IMPLANT V2 MEGAGEN W/10FT CABLE
AEU-28SYB-2 - SYBRON ENDODONTIC SYSTEM 815-1502 EU AND UK
AEU-6000-OCO-70V - IMPLANT SURGERY UNIT OCO BIOMEDICAL W/AE-70V FOOTSWITCH
AE-7P-10 - FOOTSWITCH ON/OFF 8 PIN - 10FT
AEU-7000L - IMPLANT SURGERY SYSTEM ENDO W/LIGHT
AE-23-PUMP - TUBING SET PUMP SECTION
AEU-1070PTP-70V - IMPLANT SURGERY SYSTEM TOUCH SCREEN 70NCM PTP W/AE-70V FOOTSWITCH
AE-7PMD - FOOTSWITCH ON/OFF DUAL 4 PIN MALE
AEU-7000E-MG - IMPLANT SURGERY SYSTEM ENDO MEGAGEN
AE-250-SYB - MOTOR/CABLE ASSY AE-250-SYB
AE-230L-40EXT - MOTOR/CABLE ASSY AE-230L-40EXT LED LIGHTED W/10 FT CABLE
AHP-06 - HPCE BODY CLIP
AE-225-30MMT - MOTOR/CABLE ASSY W/EXTENDED CABLE AE-225-30MMT
AEU-28KER-6 - KERR ENDODONTIC SYSTEM 065-1605 EDU WITH N AMER CORD
AEU-1070-70V - IMPLANT SURGERY SYSTEM TOUCH SCREEN 70NCM W/AE-70V FOOTSWITCH
AEU-6000ADN - IMPLANT SURGERY UNIT ADIN W/AE-70V FOOTSWITCH EURO CORD
AEU-6000-IVS-70V - IMPLANT SURGERY UNIT IMPLANT VISION W/AE-70V FOOTSWITCH
AEU-6000SWM-110 - IMPLANT SURGERY SYSTEM SWEDEN & MARTINA (US)
AE-70V2 - FOOTSWITCH VARIABLE IMPLANT V2
AEU-6000ARM-70V -IMPLANT SURGERY UNIT ARGON MEDICAL W/AE-70V FOOTSWITCH
AE-10 - TUBING LRG 5FT/MIN FOR AE-20 SILICONE 62ID X .125OD
AE-230L-40 - MOTOR/CABLE ASSY AE-230 LED LIGHTED
AE-7PM-KER - FOOTSWITCH ON/OFF 4 PIN MALE 28 KERR
AE-250-30 - MOTOR/CABLE ASSY AE-250-30
AE-2 - FTN BARB 1/16 Y PLASTIC
AHP-07 - CANNULA CLIP SET
AE-250-KER - MOTOR/CABLE ASSY AE-250-KER
AEU-6000GLI-70V - IMPLANT SURGERY SYSTEM GLIDEWELL W/AE-70V FOOTSWITCH
AE-24-BOT - TUBING SET AEU-1000 BOTTLE
AEU-6000GCR-70V - IMPLANT SURGERY UNIT GENICORE W/AE-70V FOOTSWITCH
AE-5M1 - HOLDER HNDPCE CRADLE M1
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-25SSW - SSWHITE ENDO UNIT
AEU-6000 - IMPLANT SURGERY UNIT
AEU-7000E-MIS-70V - IMPLANT SURGERY SYSTEM ENDO MIS W/AE-70V FOOTSWITCH
AE-70V2-GLI - FOOTSWITCH VARIABLE IMPLANT V2 GLIDEWELL
AE-23-BOT - TUBING SET AEU-7000 BOTTLE
AE-70V2SFI - FOOTSWITCH VARIABLE IMPLANT V2 SFI
AEU-7000LNE-70V - IMPLANT SURGERY SYSTEM ENDO W/AE-70V2-10 NEOCIS
AEU-1070 - IMPLANT SURGERY SYSTEM TOUCH SCREEN 70NCM W/AE-7PM FOOTSWITCH
AEU-28KER-4 - KERR ENDODONTIC SYSTEM 065-1601 AUS CORD
AEU-6000MG - IMPLANT SURGERY UNIT MEGAGENIMPLANT
AEU-6000SWM - IMPLANT SURGERY SYSTEM SWEDEN & MARTINA
AEU-6000ADN-110 - IMPLANT SURGERY UNIT ADIN W/AE-70V FOOTSWITCH
AEU-6000MIS-70V - IMPLANT SURGERY UNIT MIS W/AE-70V FOOTSWITCH
AEU-25 - ASEPTICO ENDO UNIT **INCL AE-4B-30
AEU-28KER-5 - KERR ENDODONTIC SYSTEM 065-1603 UK CORD
AHP-03 - HPCE IRR/CABLE CLIP PKG OF 10 HOLDS IRRIG TUBE TO HMTR CABLE
AEU-27T - ENDODONTIC SYSTEM AEU-27T
AEU-6000-70V -IMPLANT SURGERY UNIT W/AE-70V FOOTSWITCH
AEU-7000E-70V - IMPLANT SURGERY SYSTEM ENDO W/AE-70V FOOTSWITCH
AEU-1000-70V - IMPLANT SURGERY SYSTEM TOUCH SCREEN W/AE-70V FOOTSWITCH
AEU-26OS - IMPLANT SYSTEM ASEPTICO
AEU-7000L-70V - IMPLANT SURGERY SYSTEM ENDO W/AE-70V AND LIGHT
AEU-25ITL - ENDO UNIT SWEDEN & MARTINA S.p.A.
AE-4B-10 - MOTOR/CABLE ASSY AE-4B 10K
AE-3 - FTN BARB 1/16 CONNECTOR PLTD
AE-24-PUMP - TUBING SET PUMP SECTION AEU-1000
AE-20 - TUBING PUMP SET ASEPTICO
AE-4B-30 - MOTOR/CABLE ASSY AE-4B 30K
AEU-6000SDI-70V - IMPLANT SURGERY UNIT SPIRALTECH W/AE-70V FOOTSWITCH
AEU-1000-IVS-70V - IMPLANT SURGERY SYSTEM TOUCH SCREEN IVS W/AE-70V FOOTSWITCH
AE-24 - TUBING SET AEU-1000 BAG
AEU-6000PDR-70V - IMPLANT SURGERY UNIT PDR W/AE-70V FOOTSWITCH
AEU-5000 - OPERATIVE DENTAL SYSTEM
AEU-1000-OCO - IMPLANT SURGERY SYSTEM TOUCH SCREEN OCO
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
AE-70V2BSB - FOOTSWITCH VARIABLE IMPLANT V2 BLUE SKY BIO
AE-240-40 - MOTOR/CABLE ASSY AE-240-40
AEU-27A - ASEPTICO ENDODONTIC SYSTEM
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-25T - TULSA DENTAL ENDO UNIT **INCL AE-4B-30
AE-225-30 -MOTOR/CABLE ASSY AE-225-30
AEU-6000GLI - IMPLANT SURGERY SYSTEM GLIDEWELL
AEU-7000L-MIS-70V - IMPLANT SURGERY SYSTEM ENDO MIS W/AE-70V AND LIGHT
AEU-6000SAU-70V - IMPLANT SURGERY UNIT STERNGOLD W/AE-70V FOOTSWITCH
AE-230M-40 - MOTOR/CABLE ASSY AE-230M-40
AHP-04 - CANNULA W/NIPPLE & TUBING
AE-2MB - FTN MONT BLANC STNLS STEEL Y
Establishment Types
Complaint File Establishment per 21 CFR 820.198
Manufacture Medical Device for Another Party (Contract Manufacturer)
Manufacture Medical Device