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
Handpiece, Direct Drive, Ac-Powered EKX

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