Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3017604

FEI Number

3017604

Entity Name

ASEPTICO, INC.

City/State/Country

WOODINVILLE, WA, US

Establishment Address

8333 216th St SE, WOODINVILLE, WA 98072, US

Establishment Type(s)

Complaint File Establishment per 21 CFR 820.198,Manufacture Medical Device,Manufacture Medical Device for Another Party (Contract Manufacturer)

Owner / Operator

ASEPTICO, INC. (Owner Number: 3017604)

Owner / Operator Contact Address

8333 216TH ST., S.E., --, Woodinville, WA 98072, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K030163

PMA Number

N/A

All Registered 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 AEU-350 - ASEPTICO GO ULTRA PORTABLE DENTAL SYSTEM 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 A115000000000 - Calamus thermal response A122000000000 - Calamus Dual Gutta-Percha Cartridges 23G A113000000000 - Calamus Heated Plugger - Large V040532053060 - GUTTA PERCHA-Beefill Cartridge 23G A120800000000 - Calamus Dual Hand Piece Cleaning Brush V040532053045 - GUTTA PERCHA-Beefill Cartridge 25G A111000000000 - Calamus Heated Plugger - Small 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 A120900000000 - Calamus Hand Piece Heat Shield V040546000060 - Plugger root canal endodontic Beefill Heat Plugger Soft 60/6 A120600000000 - Replacement Cartridge Nut A120700000000 - Cartridge Needle Bending Tool V040532053080 - GUTTA PERCHA-Beefill Cartridge 20G A121000000000 - Calamus Dual Gutta-Percha Cartridges 20G V040548000000 - Dental Hand Instrument-Beefill Thermal Response Tip A112000000000 - Calamus Heated Plugger - Medium 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 AHP-85-SS Handpiece, contra-and right angle attachment, dental 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-26OS - IMPLANT SYSTEM ASEPTICO AEU-20 FAMILY AEU-6000 - IMPLANT SURGERY UNIT AEU-27A - ASEPTICO ENDODONTIC SYSTEM AEU-5000 - OPERATIVE DENTAL SYSTEM 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-25 FAMILY AEU-925

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
ELC	Scaler, Ultrasonic	Dental	Class 2	872.4850	2019-09-06
NRU	Chair, Dental, Without Operative Unit	Dental	Class 1	872.6250	2008-12-09
ELC	Scaler, Ultrasonic	Dental	Class 2	872.4850	2016-04-12
EKX	Handpiece, Direct Drive, Ac-Powered	Dental	Class 1	872.4200	2016-04-12
EIA	Unit, Operative Dental	Dental	Class 1	872.6640	2016-04-12
EKR	Plugger, Root Canal, Endodontic	Dental	Class 1	872.4565	2013-08-12
GEY	Motor, Surgical Instrument, Ac-Powered	General, Plastic Surgery	Class 1	878.4820	2015-03-11
EIE	Dam, Rubber	Dental	Class 1	872.6300	2007-11-06
EKX	Handpiece, Direct Drive, Ac-Powered	Dental	Class 1	872.4200	2011-10-31
EGS	Handpiece, Contra- And Right-Angle Attachment, Dental	Dental	Class 1	872.4200	2013-08-12
EGS	Handpiece, Contra- And Right-Angle Attachment, Dental	Dental	Class 1	872.4200	2007-11-06
EKM	Gutta-Percha	Dental	Class 1	872.3850	2004-10-21
EAZ	Light, Operating, Dental	Dental	Class 1	872.4630	2002-10-16
EIA	Unit, Operative Dental	Dental	Class 1	872.6640	2007-10-24
EKR	Plugger, Root Canal, Endodontic	Dental	Class 1	872.4565	2019-09-09
EJE	Frame, Rubber Dam	Dental	Class 1	872.6300	2019-07-24
EKY	Handpiece, Water-Powered	Dental	Class 1	872.4200	2026-03-24
EKM	Gutta-Percha	Dental	Class 1	872.3850	2019-09-09
EBW	Controller, Foot, Handpiece And Cord	Dental	Class 1	872.4200	2026-03-05
EGS	Handpiece, Contra- And Right-Angle Attachment, Dental	Dental	Class 1	872.4200	2026-03-05
EJG	Forceps, Rubber Dam Clamp	Dental	Class 1	872.6300	2019-07-23
EJB	Handle, Instrument, Dental	Dental	Class 1	872.4565	2004-11-16
EFB	Handpiece, Air-Powered, Dental	Dental	Class 1	872.4200	2021-03-15
EKX	Handpiece, Direct Drive, Ac-Powered	Dental	Class 1	872.4200	2011-10-31
EKX	Handpiece, Direct Drive, Ac-Powered	Dental	Class 1	872.4200	2007-11-06

Official Correspondent

No official correspondent registered.

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

ASEPTICO, INC.

View consolidated registration, premarket clearance, and recall records for this applicant.

View Entity Profile →

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K832443	California Technics, Inc.	ULTRASONIC DENTAL PROPHYLAXIS UNIT	1983-09-12
K994299	Bonart Co., Ltd.	ART-P3, MODEL P3-1-ART-A1	2000-03-06
K241065	Dentis Co., Ltd.	ChecQ (AC100)	2025-03-21
K905383	Micro Surgical Instruments Corp.	2710-000 OSCILLATING SAW, GENERAL ASSEMBLY	1991-06-18
K913369	Micro Surgical Instruments Corp.	MICRO-AIRE MODEL 2060	1991-11-01

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3017604. Last updated year: 2026. Please use registration number 3017604 when referencing this establishment in official correspondence.