Manufacturer registered with FDA
Aseptico, Inc.
Woodinville, WA, United States. Lists 18 dental device types with FDA across 1 registered establishment, and holds 17 510(k) clearances as applicant.
- Device types listed
- 18
- Brands and models
- 420
- 510(k) clearances
- 171988–2015
- Markets registered in
- 13410 registrations outside the US
- Establishments
- 1United States
510(k) clearances per year, 1980–2026
Registered in 13 markets
Where regulators' registries name Aseptico, Inc. as the manufacturer or the registration holder of a device.
RegisteredHome: United StatesOne marker per market
| Market | Regulator | Named as | Name on the registry | Registrations | Issued | Records |
|---|---|---|---|---|---|---|
| United States | FDA | Manufacturer | Aseptico, Inc. | 17 clearances | 1988–2015 | Below |
| Canada | Health Canada | Registration holder | ASEPTICO, INCORPORATED | 240 | 1998–2023 | Pure Global AI |
| Costa Rica | Ministerio de Salud | Manufacturer | ASEPTICO, INCASEPTICO, INC. | 37 | — | Pure Global AI |
| European Union | EUDAMED | Manufacturer | Aseptico, Inc. | 34 | — | Pure Global AI |
| South Korea | MFDS | Manufacturer | Aseptico Inc.Aseptico, Inc. · ASEPTICO Inc. · +2 | 28 | 1999–2019 | Pure Global AI |
| Saudi Arabia | SFDA | Manufacturer | Aseptico Inc.Aseptico, Inc. | 26 | — | Pure Global AI |
| Taiwan | TFDA | Manufacturer | ASEPTICO INC.ASEPTICO · ASEPTICO, INC. · +1 | 19 | 2006–2024 | Pure Global AI |
| Australia | TGA | Manufacturer | Aseptico Inc | 14 | 2005–2023 | Pure Global AI |
| United Kingdom | MHRA | Manufacturer | Aseptico Inc. | 7 | — | Pure Global AI |
| Israel | AMAR | Manufacturer | AsepticoAseptico, Inc. | 2 | — | Pure Global AI |
| China | NMPA | Registration holder | 美国设备帝国公司ASEPTICO INC. | 1 | — | Pure Global AI |
| Hong Kong | MDD | Manufacturer | Aseptico Inc. | 1 | 2026–2026 | Pure Global AI |
| Peru | DIGEMID | Manufacturer | ASEPTICO, INC | 1 | 2025–2025 | Pure Global AI |
Outside the US the count is of all the company's device registrations in that market, dental or not · matched by company name and country · registry data read 12 Nov 2026
Devices listed with FDA
What Aseptico, Inc. currently lists, by FDA device type, with the brand and model names on the listing.
| Device type | Category | Role | Brands and models | Listed since |
|---|---|---|---|---|
| Ac-Powered Direct Drive HandpieceEKX · Class 1 | Dental handpieces | Maker | AE-10 - TUBING LRG 5FT/MIN FOR AE-20 SILICONE 62ID X .125ODAE-2 - FTN BARB 1/16 Y PLASTICAE-20 - TUBING PUMP SET ASEPTICOAE-20Y - TUBING PUMP SET AEU-707Y YOSHIDAAE-225-30 -MOTOR/CABLE ASSY AE-225-30AE-225-30MMT - MOTOR/CABLE ASSY W/EXTENDED CABLE AE-225-30MMTAE-23 - TUBING SET AEU-7000 BAGAE-23-10 - TUBING SET 10 FT AEU-7000 BAGAE-23-BOT - TUBING SET AEU-7000 BOTTLEAE-23-PUMP - TUBING SET PUMP SECTION 130 moreAE-230A-40 - MOTOR/CABLE ASSY AE-230A-40AE-230L-40 - MOTOR/CABLE ASSY AE-230 LED LIGHTEDAE-230L-40EXT - MOTOR/CABLE ASSY AE-230L-40EXT LED LIGHTED W/10 FT CABLEAE-230M-40 - MOTOR/CABLE ASSY AE-230M-40AE-230M-40EXT - MOTOR/CABLE ASSY AE-230M-40EXT W/10 FT CABLEAE-24 - TUBING SET AEU-1000 BAGAE-24-BOT - TUBING SET AEU-1000 BOTTLEAE-24-PUMP - TUBING SET PUMP SECTION AEU-1000AE-240-40 - MOTOR/CABLE ASSY AE-240-40AE-250-30 - MOTOR/CABLE ASSY AE-250-30AE-250-30-T - MOTOR/CABLE ASSY AE-250-30-TAE-250-KER - MOTOR/CABLE ASSY AE-250-KERAE-250-SYB - MOTOR/CABLE ASSY AE-250-SYBAE-250F-30 - MOTOR/CABLE ASSY AE-250F-30AE-2MB - FTN MONT BLANC STNLS STEEL YAE-3 - FTN BARB 1/16 CONNECTOR PLTDAE-4B-10 - MOTOR/CABLE ASSY AE-4B 10KAE-4B-30 - MOTOR/CABLE ASSY AE-4B 30KAE-5M1 - HOLDER HNDPCE CRADLE M1AE-70V2 - FOOTSWITCH VARIABLE IMPLANT V2AE-70V2-10 - FOOTSWITCH VARIABLE IMPLANT V2 W/10FT CABLEAE-70V2-GLI - FOOTSWITCH VARIABLE IMPLANT V2 GLIDEWELLAE-70V2BSB - FOOTSWITCH VARIABLE IMPLANT V2 BLUE SKY BIOAE-70V2MG-10 - FOOTSWITCH VARIABLE IMPLANT V2 MEGAGEN W/10FT CABLEAE-70V2SFI - FOOTSWITCH VARIABLE IMPLANT V2 SFIAE-70V2SWM - FOOTSWITCH VARIABLE IMPLANT V2 SWMAE-7A-10 - FOOTSWITCH ON/OFF W/8PIN 10FTAE-7P - FOOTSWITCH ON/OFF 8 PINAE-7P-10 - FOOTSWITCH ON/OFF 8 PIN - 10FTAE-7PM - FOOTSWITCH ON/OFF 4 PIN MALEAE-7PM-10 - FOOTSWITCH ON/OFF 4 PIN MALE 10 FTAE-7PM-KER - FOOTSWITCH ON/OFF 4 PIN MALE 28 KERRAE-7PM-SYB28 - FOOTSWITCH ON/OFF 4 PIN MALE 28 SYBRONAE-7PM-T - FOOTSWITCH ON/OFF 4 PIN MALE TULSA DENTAL SPECIALTIESAE-7PMD - FOOTSWITCH ON/OFF DUAL 4 PIN MALEAEU-1000 - IMPLANT SURGERY SYSTEM TOUCH SCREENAEU-1000-70V - IMPLANT SURGERY SYSTEM TOUCH SCREEN W/AE-70V FOOTSWITCHAEU-1000-IVS-70V - IMPLANT SURGERY SYSTEM TOUCH SCREEN IVS W/AE-70V FOOTSWITCHAEU-1000-OCO - IMPLANT SURGERY SYSTEM TOUCH SCREEN OCOAEU-1000, AEU-1000-70V DENTAL IMPLANT MOTOR SYSTEM 50 NCMAEU-1000BSB-70V - IMPLANT SURGERY SYSTEM TOUCH SCREEN BSB W/AE-70V FOOTSWITCHAEU-1070 - IMPLANT SURGERY SYSTEM TOUCH SCREEN 70NCM W/AE-7PM FOOTSWITCHAEU-1070-70V - IMPLANT SURGERY SYSTEM TOUCH SCREEN 70NCM W/AE-70V FOOTSWITCHAEU-1070-70V-WAEU-1070-70V-W -- DENTAL IMPLANT MOTOR SYSTEM 70 NCM W/ VARIABLE WIRELESS FOOTSWITCHAEU-1070-WAEU-1070-W -- DENTAL IMPLANT MOTOR SYSTEM 70 NCM W/ ON/OFF WIRELESS FOOTSWITCHAEU-1070, AEU-1070-70V DENTAL IMPLANT MOTOR SYSTEM 70 NCMAEU-1070PTP-70V - IMPLANT SURGERY SYSTEM TOUCH SCREEN 70NCM PTP W/AE-70V FOOTSWITCHAEU-17 FAMILYAEU-20 - ASEPTICO UNIT W/ TORQUE-110V SOLD WITH AE-4B-10AEU-20 FAMILYAEU-25 - ASEPTICO ENDO UNIT **INCL AE-4B-30AEU-25 FAMILYAEU-25FP-T - FIELD PROGRAMER FOR AEU-25T (AEU25PGM)AEU-25ITL - ENDO UNIT SWEDEN & MARTINA S.p.A.AEU-25SSW - SSWHITE ENDO UNITAEU-25T - TULSA DENTAL ENDO UNIT **INCL AE-4B-30AEU-26BIC - IMPLANT SYSTEM BICONAEU-26MMT - MOTOR SYSTEM MMTAEU-26OS - IMPLANT SYSTEM ASEPTICOAEU-27A - ASEPTICO ENDODONTIC SYSTEMAEU-27DTCR -- ENDODONTIC SYSTEM AEU-27DTCRAEU-27DTCR-W -- ENDODONTIC SYSTEM AEU-27DTCR W/ ON/OFF WIRELESS FOOTSWITCHAEU-27T - ENDODONTIC SYSTEM AEU-27TAEU-27TS - ENDODONTIC SYSTEM AEU-27TS (SCHOOL GRANT PMKEM1SPCL)AEU-28KER-1 - KERR ENDODONTIC SYSTEM 065-1600 N AMER CORDAEU-28KER-2 - KERR ENDODONTIC SYSTEM 065-1602 EU CORDAEU-28KER-4 - KERR ENDODONTIC SYSTEM 065-1601 AUS CORDAEU-28KER-5 - KERR ENDODONTIC SYSTEM 065-1603 UK CORDAEU-28KER-6 - KERR ENDODONTIC SYSTEM 065-1605 EDU WITH N AMER CORDAEU-28SYBAEU-28SYB-1 - SYBRON ENDODONTIC SYSTEM 815-1500 N AMER AND AUSAEU-28SYB-2 - SYBRON ENDODONTIC SYSTEM 815-1502 EU AND UKAEU-350 - ASEPTICO GO ULTRA PORTABLE DENTAL SYSTEMAEU-5000 - OPERATIVE DENTAL SYSTEMAEU-525 FAMILYAEU-6000 - IMPLANT SURGERY UNITAEU-6000-70V -IMPLANT SURGERY UNIT W/AE-70V FOOTSWITCHAEU-6000-70V-WAEU-6000-70V-W -- IMPLANT SURGERY UNIT W/ VARIABLE WIRELESS FOOTSWITCHAEU-6000-IVS-70V - IMPLANT SURGERY UNIT IMPLANT VISION W/AE-70V FOOTSWITCHAEU-6000-OCO - IMPLANT SURGERY UNIT OCO BIOMEDICALAEU-6000-OCO-70V - IMPLANT SURGERY UNIT OCO BIOMEDICAL W/AE-70V FOOTSWITCHAEU-6000-WAEU-6000-W -- IMPLANT SURGERY UNIT W/ ON/OFF WIRELESS FOOTSWITCHAEU-6000ADN - IMPLANT SURGERY UNIT ADIN W/AE-70V FOOTSWITCH EURO CORDAEU-6000ADN-110 - IMPLANT SURGERY UNIT ADIN W/AE-70V FOOTSWITCHAEU-6000ARM-70V -IMPLANT SURGERY UNIT ARGON MEDICAL W/AE-70V FOOTSWITCHAEU-6000GCR-70V - IMPLANT SURGERY UNIT GENICORE W/AE-70V FOOTSWITCHAEU-6000GLI - IMPLANT SURGERY SYSTEM GLIDEWELLAEU-6000GLI-70V - IMPLANT SURGERY SYSTEM GLIDEWELL W/AE-70V FOOTSWITCHAEU-6000MG - IMPLANT SURGERY UNIT MEGAGENIMPLANTAEU-6000MIS-70V - IMPLANT SURGERY UNIT MIS W/AE-70V FOOTSWITCHAEU-6000PDR-70V - IMPLANT SURGERY UNIT PDR W/AE-70V FOOTSWITCHAEU-6000PTP-70V -IMPLANT SURGERY UNIT PALTOP W/AE-70V FOOTSWITCHAEU-6000SAU - IMPLANT SURGERY UNIT STERNGOLDAEU-6000SAU-70V - IMPLANT SURGERY UNIT STERNGOLD W/AE-70V FOOTSWITCHAEU-6000SDI-70V - IMPLANT SURGERY UNIT SPIRALTECH W/AE-70V FOOTSWITCHAEU-6000SWM - IMPLANT SURGERY SYSTEM SWEDEN & MARTINAAEU-6000SWM-110 - IMPLANT SURGERY SYSTEM SWEDEN & MARTINA (US)AEU-7000E - IMPLANT SURGERY SYSTEM ENDOAEU-7000E-70V - IMPLANT SURGERY SYSTEM ENDO W/AE-70V FOOTSWITCHAEU-7000E-70V-WAEU-7000E-70V-W -- IMPLANT SURGERY SYSTEM ENDO W/ VARIABLE WIRELESS FOOTSWITCHAEU-7000E-MG - IMPLANT SURGERY SYSTEM ENDO MEGAGENAEU-7000E-MIS-70V - IMPLANT SURGERY SYSTEM ENDO MIS W/AE-70V FOOTSWITCHAEU-7000E-SFI-70V - IMPLANT SURGERY SYSTEM ENDO SHATKIN W/AE-70V FOOTSWITCHAEU-7000E-WAEU-7000E-W -- IMPLANT SURGERY SYSTEM ENDO W/ ON/OFF WIRELESS FOOTSWITCHAEU-7000L - IMPLANT SURGERY SYSTEM ENDO W/LIGHTAEU-7000L-70V - IMPLANT SURGERY SYSTEM ENDO W/AE-70V AND LIGHTAEU-7000L-70V-WAEU-7000L-70V-W --IMPLANT SURGERY SYSTEM ENDO W/ LIGHT AND VARIABLE WIRELESS FOOTSWITCHAEU-7000L-MIS-70V - IMPLANT SURGERY SYSTEM ENDO MIS W/AE-70V AND LIGHTAEU-7000L-WAEU-7000L-W -- IMPLANT SURGERY SYSTEM ENDO W/ LIGHT ON/OFF AND WIRELESS FOOTSWITCHAEU-7000L/7000L-70V IMPLANT SURGERY SYSTEM ENDO W/LIGHTAEU-7000LNE-70V - IMPLANT SURGERY SYSTEM ENDO W/AE-70V2-10 NEOCISAEU-7000LS - IMPLANT SURGERY SYSTEM ENDO SWEDEN & MARTINA W/AE-70V AND LIGHTAEU-707 FAMILYAEU-925AHP-03 - HPCE IRR/CABLE CLIP PKG OF 10 HOLDS IRRIG TUBE TO HMTR CABLEAHP-04 - CANNULA W/NIPPLE & TUBINGAHP-05 - HPCE IRR/CONTRA ANGLE CLIPAHP-06 - HPCE BODY CLIPAHP-07 - CANNULA CLIP SETAHP-07T - TUBE EXTERNAL IRRIGATION 6.5" L 42ID X .120ODENDODONTIC SYSTEM AEU-27DTCRENDODONTIC SYSTEM AEU-27DTCR W/ ON/OFF WIRELESS FOOTSWITCH | 2007 |
| Operative Dental UnitEIA · Class 1 | Dental chairs & operative units | Maker | AA-100-110 -COMPRESSOR AIRPAC III 110VAA-100-220 - COMPRESSOR AIRPAC III 220VAA-12CSB - BRKT ADU-12 CASE LID STANDOFF BRACKET KITAA-12HVE - ADAPTER HVE ADU-12 TASKFORCEAA-20 - VACUUM RECHARGEABLE PORTABLEAA-20A - AUXILIARY ARM MOBILE DENTAL CART SYSTEM AMC-20 / AMC-25AA-21ST - VACUUM HIGH VOLUME AVS INSTALLED ON ADU-04STAA-25ST - VACUUM SALIVA EJECTOR FOR USE ON ADU-04STAA-26SS - COLLECTOR DRY ORAL CUP STAINLS STEEL W/ STRAINERAA-525AMAL - AMALGAM SEPARATOR AEU-525 PORTABLE 41 moreAA-96EXT - AIR EXTENSION LINE 25FTADU-01C - CASE PORTABLE SUPPLY 5 DRAWERADU-03ST - THREE WAY AIR-WATER SYRINGE W/ STANDADU-04 - TWO HPCE MINI CONTROLADU-04ST - TWO HPCE MINI CONTROL W/ STANDADU-07 - HPCE CONTROL MANUAL SYSTEMADU-07A - HPCE CONTROL AUTOMATIC SYSTEM ECONOMYADU-12DCE - ASEPTICO TASK FORCE DELUXEADU-17A - EXPRESS AIR PORTABLE UNITADU-17A2 - EXPRESS AIR 2 PORTABLE UNITADU-17X - EXPRESS II PORTABLE UNITADU-17X2 - EXPRESS PLUS II PORTABLE UNITADU-20B - COMPRICART IIADU-22 - PORTACART ECONOMY CARTADU-25 - ENDO-CART BASE MODELAE-200-30 - MOTOR/CABLE ASSY W/LIGHT & H2OAE-205-30EXT - MOTOR/CABLE ASSY 30K EXTERNAL WATERAE-240SC-40 - MOTOR/CABLE ASSY AE-240SC-40 W/SHORT CABLEAEU-14 FAMILYAEU-350 - ASEPTICO GO ULTRA PORTABLE DENTAL SYSTEMAEU-525 - TRANSPORT III PORTABLE DUAL VOLT UNIT 110/220VAEU-525 FAMILYAEU-525CF - TRANSPORT III COMMAND FIELD DUAL VOLTAGE UNIT 110/220VAEU-525CFH - TRANSPORT III WITH HANDPIECES MILITARY 110/220V DUAL VOLTAGEAEU-525S - TRANSPORT III W/SCALER DUAL VOLT UNIT 110/220VAMC-15 Basic Mobile Dental CartAMC-20 FAMILYAMC-25 - MOBILE DENTAL CART AMC-25AMC-25 FAMILYAMC-25CF - MOBILE DENTAL CART AMC-25CFAMC-25CF-USAF - MOBILE DENTAL CART AMC-25CF-USAFASC-10-ACC - ACCESSORY KIT ASC-10 SCALERASC-10L-ACC - ACCESSORY KIT W/SLEEVE FOR LED ASC-10 SCALERASU-12-110 - AUTOCLAVE PORTABLE PRESTIGE CLASSIC 110VASU-12-230 - AUTOCLAVE PORTABLE PRESTIGE CLASSIC 230VATC-03CF - COMMAND AIR PORTABLE TRAY 6520-01-446-6263ATC-12V2 - CART 4 SHELF ADJUSTABLE WITH AC POWERNWS-7I - WATER SYS SELF-CONT INSTALLED NON-STERILENWS-8 - WATER SYSTEMTA-1 - SYRINGE TIP AUTOCLAVABLE 3-WAYTA-90VC - SYRINGE TA-90 VALVE CARTRIDGE | 2007 |
| Dental Contra- and Right-Angle Attachment HandpieceEGS · Class 1 | Dental handpieces | Lister | AHP-09 - ASEPTISPRAY HPCE LUBRICANT WITH E TYPE NOZZLE ADAPTERAHP-101 - HPCE 1:1 STRT LOW SPEED DORIOTAHP-11 - ONESTEP LUBRICANT WITH E TYPE NOZZLE ADAPTERAHP-50 - MOTOR AIR 20K RPM 4HAHP-50MK - MOTOR AIR 4-HOLE E-TYPE 20K RPMAHP-51 - HPCE 1:1 STRAIGHT E TYPE LAHP-53 - HPCE 1:1 DORIOT CONTRAAHP-55 - HPCE HI-SPEED ECONOMY 4HAHP-55T - TURBINE FOR AHP-55AHP-56FUE - HPCE 4:1 CONTRA FUE DRIVE 29 moreAHP-62MN - HPCE 16:1 MICRO-NITI CONTRA ANGLE LATCH HEADAHP-62MNP - HPCE 16:1 MICRO HEAD PUSH BUTTONAHP-63MBFO-XL - HPCE 1:1 CONTR W/FIB OPT & WATER MONT BLANC EVOLUTIONAHP-63NAK - HPCE 1:1 CONTRA LATCH ANGLEAHP-64 - HANDPIECE STRAIGHT 1:1 40KAHP-64MKI - HANDPIECE STRAIGHT 1:1 40k w/ INTERNAL IRRIGATIONAHP-65TI - HPCE 1:3 INCREASER W/ WATERAHP-65TI-FO - HPCE 1:3 INCREASER W/ WATER W/ FIB OPTAHP-71TI-X - HPCE 1:5 INCREASER W/WATERAHP-72C-FO - HPCE 1:5 CONTRA INCREASER SPEED W/FIBER OPT & AIRAHP-77D-NOZ - WATER NOZZLE AHP-77D (H265A001)AHP-77DS - HPCE ORAL SURGERY 1:2 NSK STRAIGHTAHP-82T - HPCE TORQUE HEAD K-STYLE VECTOR FIBER OPTIC HIGH SPEEDAHP-85-I - HPCE 20:1 CONTRA ANGLE LATCH IMPULSIONAHP-85-SS Handpiece, contra-and right angle attachment, dentalAHP-85MB-CAN - CANNULA MONT BLANC INTERNALAHP-85MB-CLP - CLIP MONT BLANC EXTERNALAHP-85MB-CS - DEPTH STOP FOR AHP-85MB-C HANDPIECEAHP-85MB-CX - HPCE 20:1 PB CONTRA ANGLE MONT BLANC CONTROLAHP-85MB-STP - DEPTH STOP ONLY FOR AHP-85MB-CAHP-85MB-X - HPCE 20:1 PUSH BTN CONTRA ANGLE MONT BLANC EVOLUTIONAHP-85MBFO-CX - HPCE 20:1 PUSH BTN CONTRA ANG W/FIB OPT MONT BLANC CONTROLAHP-85P-I - HPCE 20:1 PUSH BUTTON CONTRA REINFORCED IMPULSIONAHP-88MN - HPCE 8:1 MICRO-NITI CONTRA ANGLE LATCH HEADAHP-88MNP - HPCE 8:1 MICRO-NITI PUSH BUTTONAHP-96 - HPCE CHAMP-AIR 4-HOLE PUSH BUTTON HIGHSPEED REF#AC5000-4PAHP-96MK - HANDPIECE 4-HOLE PB STD HEAD HIGHSPEEDAHP-97 - HPCE HIGH SPEED 5-H W/FIBER OP (135985)Mont Blanc Handpieces | 2007 |
| Gutta-PerchaEKM · Class 1 | Root canal filling materials | Maker | BNSG1QA0025G Gutta-Smart GP Crtg 25G-10 PackBNSGS1QA0020G Gutta-Smart GP Crtg 20G 10-PackBNSGS1QA0023G Gutta-Smart GP Crtg 23G-10 PackGP-018CP-DS - GUTTA PERCHA 18 PACKAGED CARTRIDGE FOR AEU-65-DSGP-018CP-ROW - GUTTA PERCHA 18 PACKAGED CARTRIDGE FOR AEU-65-ROWGP-018E20P - GUTTA PERCHA 18 PACKAGED CARTRIDGE EASY FLOW MATERIAL (CALG25)GP-018E20P-VDW - GUTTA PERCHA 18 FOR VDW PACKAGED-EASY FLOW FILL MATERIALGP-025CP-DS - GUTTA PERCHA 25 PACKAGED CARTRIDGE FOR AEU-65-DSGP-025CP-ROW - GUTTA PERCHA 25 PACKAGED CARTRIDGE FOR AEU-65-ROWGP-025EP - GUTTA PERCHA 25 PACKAGED ENDODENT MATERIAL (CALG232) 12 moreGP-025SP - GUTTA PERCHA 25 PACKAGED CARTRIDGE STANDARD FILL MATERIAL (CALG23)GP-025SP-MF - GUTTA PERCHA 25 MAILLEFER / 23GGP-025SP-VDW - GUTTA PERCHA 25 FOR VDW PACKAGED-STANDARD FILL MATERIALGP-035CP-DS - GUTTA PERCHA 35 PACKAGED CARTRIDGE FOR AEU-65-DSGP-035CP-ROW - GUTTA PERCHA 35 PACKAGED CARTRIDGE FOR AEU-65-ROWGP-035EP - GUTTA PERCHA 35 PACKAGED ENDODENT MATERIAL (CALG202)GP-035SP - GUTTA PERCHA 35 PACKAGED CARTRIDGE STANDARD FILL MATERIAL (CALG20)GP-035SP-MF - GUTTA PERCHA 35 MAILLEFER / 20GGP-035SP-VDW - GUTTA PERCHA 35 FOR VDW PACKAGED-STANDARD FILL MATERIALV040532053045 - Beefill Guttapercha Cartridge 25G = 0,45mmV040532053060 - Beefill Guttapercha Cartridge 23G = 0,6mmV040532053080 - Beefill Guttapercha Cartridge 20G = 0,8mm | 2004 |
| Endodontic Root Canal PluggerEKR · Class 1 | Dental hand instruments | Maker | A111000000000 - Calamus Heated Plugger - SmallA112000000000 - Calamus Heated Plugger - MediumA113000000000 - Calamus Heated Plugger - LargeA115000000000 - Calamus thermal responseA120600000000 - Replacement Cartridge NutA120700000000 - Cartridge Needle Bending ToolA120800000000 - Calamus Dual Hand Piece Cleaning BrushA120900000000 - Calamus Hand Piece Heat ShieldA121000000000 - Calamus Dual Gutta-Percha Cartridges 20GA122000000000 - Calamus Dual Gutta-Percha Cartridges 23G 42 moreA130000000000 - Calamus DualA130000000000 - Calamus Dual - EURA130000000002 - Calamus DualA130000000002 - Calamus Dual - CHA130000000022 - Calamus DualA130000000022 - Calamus Dual - AUSA130000000026 - Calamus DualA130000000026 - Calamus Dual - JAPA130000000033 - Calamus DualA130000000033 - Calamus Dual - UKB00GS1Q00LRG Gutta-Smart Electric Heat Plugger, LargeB00GS1Q100000 Gutta-Smart Thermal Reponse TipB00GS1Q100HES Gutta-Smart Heating ElementB00GS1Q100MED Gutta-Smart Electric Heat Plugger, MediumB00GS1Q100SML Gutta-Smart Electric Heat Plugger, SmallB00GSIQ000BAS - Gutta-Smart Base StationB00GSIQ000KIT - Gutta-Smart Cordless Obturation SystemB00GSIQ100000 - Gutta-Smart Thermal Response TipB00GSIQ100LRG - Gutta-Smart Electric Heat Plugger, LargeB00GSIQ100MED - Gutta-Smart Electric Heat Plugger, MediumB00GSIQ100SML - Gutta-Smart Electric Heat Plugger, SmallBCPGSIQ000BET - Gutta-Smart Cannula BenderBCPGSIQ000CAP - Gutta-Smart Cleaning CapsBCPGSIQ000FLO - Gutta-Smart Flow HandpieceBCPGSIQ000HES - Gutta-Smart Flow HeaterBCPGSIQ000PAK - Gutta Smart Pack HandpieceBCPGSIQ000RPC - Gutta-Smart Remote Power CordBNSGSIQA0020G - Gutta-Smart GP Crtg 20G 10-packBNSGSIQA0023G - Gutta-Smart GP Crtg 23G 10-packBNSGSIQA0025G - Gutta-Smart GP Crtg 25G 10-packBSPGSIQ000001 - Gutta-Smart Charger BaseBSPGSIQ000002 - Gutta-Smart Charger top with LCDBSPGSIQ000003 - Gutta-Smart Charger FeetBSPGSIQ000004 - Fastener screwV040532053045 - GUTTA PERCHA-Beefill Cartridge 25GV040532053060 - GUTTA PERCHA-Beefill Cartridge 23GV040532053080 - GUTTA PERCHA-Beefill Cartridge 20GV040541000000 - Dental Hand Instrument-Beefill 2in1 (Obturation Device)V040546000050 - Plugger root canal endodontic Beefill Heat Plugger Soft 50/5V040546000060 - Plugger root canal endodontic Beefill Heat Plugger Soft 60/6V040547000040 - Plugger root canal endodontic Beefill Heat Plugger Standard 40/3V040548000000 - Dental Hand Instrument-Beefill Thermal Response Tip | 2013 |
| Ultrasonic ScalerELC · Class 2 | Ultrasonic scalers | Maker | AEU-350 - ASEPTICO GO ULTRA PORTABLE DENTAL SYSTEMAEU-350-WAEU-350S - ASEPTICO GO ULTRA PORTABLE DENTAL SYSTEM W/ScalerAEU-350S-WAEU-525 - TRANSPORT III PORTABLE DUAL VOLT UNIT 110/220VAEU-525 FAMILYAEU-525CF - TRANSPORT III COMMAND FIELD DUAL VOLTAGE UNIT 110/220VAEU-525CF Transport III Command Field Dual VoltageAEU-525CFH - TRANSPORT III WITH HANDPIECES MILITARY 110/220V DUAL VOLTAGEAEU-525CFH-14 - TRANSPORT III WITH HANDPIECES and TIPS MILITARY 110/220V DUAL VOLTAGE 2 moreAEU-525FO - TRANSPORT III W/FIBER OPTICS DUAL VOLT PORTABLE UNITAEU-525S - TRANSPORT III W/SCALER DUAL VOLT UNIT 110/220V | 2016 |
| Orthodontic WireDZC · Class 1 | Orthodontic wires & bands | Maker | AMA-09A - KIT CUSPID CHAIN / GRIDAMA-09A2 - KIT BICUSPID CHAIN / GRIDAMA-09A3 - KIT INCISOR CHAIN / GRIDAMA-09D - LINGUAL BUTTONS PKG/6 | 2019 |
| Dental Hand InstrumentsDZN · Class 1 | Dental hand instruments | Maker | B00GS1Q000BAS Gutta-Smart Base StationB00GS1Q000KIT Gutta-Smart KitBCPGS1Q000BET Gutta-Smart Cannula BenderBCPGS1Q000CAP Gutta-Smart Cleaning CapsBCPGS1Q000FLO Gutta-Smart Flow HandpieceBCPGS1Q000PAK Gutta-Smart Pack Handpiece | 2019 |
| Dental Operating LightEAZ · Class 1 | Dental operating lights | Maker | ALU-40LED - LIGHT PORTABLE LED OPERATORYALU-40LED-CF - LIGHT PORTABLE LED OPERATORY 6520-01-600-8241ALU-40MOM - LIGHT PORTABLE LED OPERATORY MOMALU-40MOM - LIGHT PORTABLE LED OPERATORY W/STAND MOM | 2002 |
| Handpiece and Cord Foot ControllerEBW · Class 1 | — | Lister | AHP-85-SS Handpiece, contra-and right angle attachment, dental | 2026 |
| Rubber Dam ClampEEF · Class 1 | Rubber dam systems | Lister | K-0 - RUBBER DAM CLAMP BICUSPID #0K-00 - RUBBER DAM CLAMP BICUSPID #00K-1 - RUBBER DAM CLAMP BICUSPID #1K-12A - RUBBER DAM CLAMP MOLAR #12AK-138 - RUBBER DAM CLAMP MOLAR #138K-139 - RUBBER DAM CLAMP MOLAR # 139K-13A - RUBBER DAM CLAMP MOLOR #13AK-14 - RUBBER DAM CLAMP MOLAR #14K-14A - RUBBER DAM CLAMP MOLAR #14AK-15 - RUBBER DAM CLAMP MOLAR #15 42 moreK-18 - RUBBER DAM CLAMP MOLAR #18K-1A - RUBBER DAM CLAMP BICUSPID #1K-2 - RUBBER DAM CLAMP BICUSPID #2K-200 - RUBBER DAM CLAMP MOLAR #200K-201 - RUBBER DAM CLAMP MOLAR #201K-202 - RUBBER DAM CLAMP MOLAR #202K-203 - RUBBER DAM CLAMP MOLAR #203K-205 - RUBBER DAM CLAMP MOLAR #205K-206 - RUBBER DAM CLAMP BICUSPID #206K-207 - RUBBER DAM CLAMP BICUSPID #207K-208 - RUBBER DAM CLAMP BICUSPID #208K-209 - RUBBER DAM CLAMP BICUSPID #209K-210 - RUBBER DAM CLAMP LABIAL #210K-211 - RUBBER DAM CLAMP LABIAL #211K-212 - RUBBER DAM CLAMP LABIAL #212K-22 - RUBBER DAM CLAMP BICUSPID #22K-25 - RUBBER DAM CLAMP MOLAR #25K-26 - RUBBER DAM CLAMP MOLAR #26K-27 - RUBBER DAM CLAMP BICUSPID #27K-28 - RUBBER DAM CLAMP MOLAR #28K-29 - RUBBER DAM CLAMP BICUSPID #29K-2A - RUBBER DAM CLAMP BICUSPID #2AK-3 - RUBBER DAM CLAMP BICUSPID #3K-4 - RUBBER DAM CLAMP MOLAR #4K-5 - RUBBER DAM CLAMP MOLAR #5K-51 - RUBBER DAM CLAMP MOLAR #51K-56 - RUBBER DAM CLAMP MOLAR #56K-56A - RUBBER DAM CLAMP MOLAR #56AK-6 - RUBBER DAM CLAMP LABIAL #6K-7 - RUBBER DAM CLAMP MOLAR #7K-7A - RUBBER DAM CLAMP MOLAR #7AK-8 - RUBBER DAM CLAMP MOLAR #8K-8A - RUBBER DAM CLAMP MOLAR #8AK-9 - RUBBER DAM CLAMP LABIAL #9K-90N - RUBBER DAM CLAMP LABIAL #90NK-G1 - RUBBER DAM GAUZE CLAMP #G1K-G2 - RUBBER DAM GAUZE CLAMP #G2K-P1 - RUBBER DAM CLAMP PEDO #P1K-P2 - RUBBER DAM CLAMP PEDO #P2K-W2A - RUBBER DAM CLAMP BICUSPID #W2AK-W3 - RUBBER DAM CLAMP MOLAR W3K-W8A - RUBBER DAM CLAMP MOLAR #W8A | 2019 |
| Dental Air-Powered HandpieceEFB · Class 1 | Dental handpieces | Lister | AHP-50MK - MOTOR AIR 4-HOLE E-TYPE 20K RPM = MK-Dent PN# AM0004 Airmotor, 4 holes, 2000 rpmAHP-63MK - HANDPIECE 1:1 CONTRA LATCH = MK-Dent PN# LB11/11C BASIC LINE Contra Angle HandpieceAHP-72MK-FO - HANDPIECE 1:5 CONTRA W/FO & WATER INCREASER = MK-Dent PN# LE15L ECO LINE Contra Angle Handpiece with LightAHP-82MK-QD - HANDPIECE KAVO 6-PIN LED FO QUICK COUPLER = MK-Dent PN# QC6016KW Quick Connector, 4 holes (6 pins)AHP-96MK - HANDPIECE 4-HOLE PB STD HEAD HIGHSPEED = MK-Dent PN# HE17 ECO LINE High Speed HandpieceAHP-97MK - HANDPIECE 5-HOLE PB STD HEAD W/FO HIGHSPEED = MK-Dent PN# HE16L ECO LINE High Speed Handpiece with Light | 2021 |
| Rubber DamEIE · Class 1 | Rubber dam systems | Maker | I-70BM - HANDIDAM W/PLASTIC FRAME BLUE PKG OF 20I-70BM-100 - HANDIDAM ASEPTICO MED BLUE-100 PKG OF 100I-70K - CLAMP KIT HANDIDAMI-70LF - HANDIDAM-LF LATEX FREE RUBBER DAM MAUVE PKG OF 20I-70LF-100 - HANDIDAM-LF LATEX FREE RUBBER DAM MAUVE PKG OF 100 | 2007 |
| Dental Instrument HandleEJB · Class 1 | Dental hand instruments | Maker | AEU-45 FAMILY | 2004 |
| Rubber Dam FrameEJE · Class 1 | Rubber dam systems | Lister | I-16 - RUBBER DAM FRAME ADULTI-17 - RUBBER DAM FRAME CHILD | 2019 |
| Rubber Dam Clamp ForcepsEJG · Class 1 | Rubber dam systems | Lister | I-14 - FORCEP RUBBER DAMI-15 - TEMPLATE RUBBER DAMI-18 - PUNCH RUBBER DAMI-19 - RUBBER DAM PUNCH (IVORY STYLE) | 2019 |
| Cartridge SyringeEJI · Class 2 | Dental needles & syringes | Lister | CAL-2118 Calaject | 2022 |
| Dental Chair without Operative UnitNRU · Class 1 | Dental chairs & operative units | Maker | ADC-01 -ASEPTICHAIR WITH CASEADC-01-BLU - ASEPTICHAIR BLUE WITH CASEADC-01-RED - ASEPTICHAIR RED WITH CASEADC-01CS -ASEPTICHAIR WITH CASEADC-01P-RED - ASEPTICHAIR RED PEDO WITH CASEADC-02 - ADVANCED PORTABLE CHAIRADC-02-BLU - ADVANCED PORTABLE CHAIR BLUEADC-02CF - MILITARY PORTABLE CHAIRADC-08 - ASEPTISTOOL PORTABLE OPERATOR STOOLADC-08-BLU - ASEPTISTOOL PORTABLE OPERATOR STOOL BLUE 8 moreADC-08-RED - ASEPTISTOOL PORTABLE OPERATOR STOOL - REDADC-08CF - COMMAND FIELD PORTABLE OPERATOR STOOLS 6520-01-456-5406ADC-08S - ASEPTISTOOL MILITARY SINGLE SOFT CASE NSN 6520-01-456-5467ADC-09CF - COMMAND FIELD ADVANCED MIL OPERATOR STOOLSADC-09S - COMMAND FIELD ADVANCED MIL OPERATOR STOOL SOFT CASEADC-10 - ADVANCED PORTABLE OPERATOR STOOLADC-10-BLU - ADVANCED PORTABLE OPERATOR STOOL BLUEADC-10-RED - ASEPTISTOOL RED PORTABLE OPERATOR STOOL | 2008 |
Source: FDA establishment registration & device listing, 510(k) and product classification files · FDA data as of 2 Nov 2026 · snapshot 12 Nov 2026
510(k) clearances
Clearances on which FDA names Aseptico, Inc. as the applicant.
| Decided | 510(k) | Device | Device type |
|---|---|---|---|
| 28 May 2015 | K150129 | AEU-7000L-70V IMPLANT/ENDODONTIC DENTAL SYSTEM (LIGHTED VERSION) | EKX Ac-Powered Direct Drive Handpiece |
| 31 Dec 2014 | K142124 | AEU-6000 IMPLANT / ENDODONTIC DENTAL SYSTEM | EKX Ac-Powered Direct Drive Handpiece |
| 14 Aug 2013 | K130693 | AEU-525 TRANSPORT III PORTABLE DENTAL SYSTEM | ELC Ultrasonic Scaler |
| 14 Jun 2011 | K111078 | AEU-26L ELCTRONIC ENDODONTIC SYSTEM | EKX Ac-Powered Direct Drive Handpiece |
| 11 Apr 2011 | K101332 | AMC-20 PORTABLE DENTAL CART MODEL AMC-20 | EIA Operative Dental Unit |
| 28 Feb 2011 | K103399 | GENERAL DENISTRY MOTOR | EKX Ac-Powered Direct Drive Handpiece |
| 11 Apr 2007 | K070866 | ASC-12 PIEZOELECTRIC SCALER | ELC Ultrasonic Scaler |
| 3 May 2005 | K051077 | E-TYPE STRAIGHT HANDPIECE, MODEL AHP-101 | EGS Dental Contra- and Right-Angle Attachment Handpiece |
| 18 Mar 2005 | K050201 | AEU-14CF EXPENDITION | EIA Operative Dental Unit |
| 3 Mar 2003 | K030163 | ASEPTICO VCT VERSATILE COMMAND TECHNOLOGY MODEL AEU-925 | EKX Ac-Powered Direct Drive Handpiece |
| 24 Oct 2002 | K022217 | AEU-425 TRANSPORT II PORTABLE DENTAL SYSTEM | EIA Operative Dental Unit |
| 4 Mar 2002 | K020137 | AHP-66 4:1 REDUCTION CONTRANGLE: AHP-88 8:1 REDUCTION CONTRANGLE: AHP-88MP 8:1 REDUCTION CONTRANGLE - PUSH BUTTON | EGS Dental Contra- and Right-Angle Attachment Handpiece |
| 22 Jul 1993 | K923157 | DENTAL RUBBER DAM | EIE Rubber Dam |
| 28 Dec 1992 | K923163 | RUBBER DAM CLAMP | EIE Rubber Dam |
| 20 Feb 1991 | K905401 | ASEPTIMINI UNIT, ADU-10 | EIA Operative Dental Unit |
| 3 Feb 1989 | K884828 | HANDIDAM | EIE Rubber Dam |
| 8 Dec 1988 | K882526 | DELIVERY PUMP FOR STERILE IRRIGANT & HANDPIECE DR. | EIA Operative Dental Unit |
Some of these clearances are listed with FDA today by another company: Bicon, LLC (2), Park Dental Research Corp (2), SWEDEN & MARTINA S.p.A. (1), Sybron Dental Specialties (1).
Also lists devices cleared under other names
Aseptico, Inc. lists these devices with FDA today. The clearance names a different applicant, as happens after a rename, an acquisition or a private-label agreement.
Original applicants: Saeshin Precision Co., Ltd. (1), MK-dent GmbH (1).
| Decided | 510(k) | Device | Applicant | Device type |
|---|---|---|---|---|
| 11 Feb 2021 | K201292 | TRAUS SIP20 | Saeshin Precision Co., Ltd. | EBW Handpiece and Cord Foot Controller |
| 3 Oct 2005 | K051872 | MK-DENT LOW SPEED HANDPIECES AND ACCESSORIES INCLUDING SPARE PARTS, TUBINGS, AND LIGHT POWER SYSTEM, MODELS: LS2011 | MK-dent GmbH | EFB Dental Air-Powered Handpiece |
Registered establishments
| Establishment | Location | What it does |
|---|---|---|
| ASEPTICO, INC.FDA reg. 3017604 | WOODINVILLE, WA, United States | Complaint file establishment, Contract manufacturer, Manufacturer for export, Manufacturer |
Sources
FDA establishment registration & device listing (search FDA, owner/operator 3017604). FDA 510(k) premarket notification file. FDA data as of 2 Nov 2026; snapshot 12 Nov 2026. The location shown is the address on FDA's record.