Manufacturer registered with FDA
A-dec, Inc.
Newberg, OR, United States. Lists 19 dental device types with FDA across 1 registered establishment, and holds 68 510(k) clearances as applicant.
- Device types listed
- 19
- Brands and models
- 160
- 510(k) clearances
- 681989–2022
- Markets registered in
- 411 registrations outside the US
- Establishments
- 1United States
510(k) clearances per year, 1980–2026
Registered in 4 markets
Where regulators' registries name A-dec, 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 | A-dec, Inc. | 68 clearances | 1989–2022 | Below |
| Taiwan | TFDA | Manufacturer | A-DEC INC. | 7 | 2005–2026 | Pure Global AI |
| Israel | AMAR | Manufacturer | A-dec, Inc.Adec Inc. | 2 | — | Pure Global AI |
| Peru | DIGEMID | Manufacturer | A-DEC INC. | 2 | 2022–2023 | 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 A-dec, 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 |
|---|---|---|---|---|
| Dental Air-Powered HandpieceEFB · Class 1 | Dental handpieces | Lister | Air High Speed HandpiecesAir Low Speed HandpieceAlegraAM-20 MWAM-20 SDAM-20RMAM-5 MWAM-5 SDAssistina Maintenance SystemHigh Speed Handpieces 9 moreImplant Sterile TubingMicro Air Motor A-25LTMicro Air Motor LT25Micro Air Motors:Midwest Endo Unlit HandpieceMidwest Implant HandpieceRoto-QuickSyneaTrend | 2007 |
| Operative Dental UnitEIA · Class 1 | Dental chairs & operative units | Maker | A-dec 200 Dental ChairA-dec 200 Dental Delivery SystemA-dec 200 Dental LightA-dec 200 Support Center, Cuspidor, Assistant's InstrumentationA-dec 200, 300, 400, 500A-dec 300A-dec 300pro Cart Delivery SystemA-dec 300pro Delivery SystemsA-dec 341sp Specialty Delivery SystemA-dec 500 22 moreA-dec 500pro Delivery SystemsA-dec 500sta Assistant's InstrumentationAssistant's InstrumentationCascade 2615 Assistant's CartCascade 2671 Due Cart Deliver SystemDecadeDecade 2561 Duo CartDecade 2562 Doctor's CartDelivery SystemPac 1 3420 Field UnitPac 1 3420 Institutional UnitPac 1 3420 Self-Contained UnitPerformerPerformer Assistant's Instrumentation 8500Performer Delivery System 8100Radius/CascadeRefurbished Assistant's InstrumentationRefurbished Delivery SystemSelf-Contained Water System (with ICX as accessory)3181 Duo Delivery System4631 Duo Delivery System4635 Assistants Instrumentation | 2007 |
| Handpiece and Cord Foot ControllerEBW · Class 1 | — | Maker | A-dec XC10 Electric MotorEA-30EA-40LTEA-50LTEA-51LTEA-52LEDEA-53EA-53TTElectric MotorMidwest Electric Motor 3 moreMotor ControllerNLX NanoNLX Plus | 2007 |
| Dental Operating LightEAZ · Class 1 | Dental operating lights | Maker | A-dec 374L LED Dental Lt, Central Cabinet MtA-dec 375L LED Dental Lt, Wall/Side Cabinet MtA-dec 376L LED Dental Lt, Ceiling MtA-dec 377L LED Dental Lt, Track MtA-dec 378L LED Dental Lt, Simulator MtA-dec 570L LED RetrofitA-dec 571L Dental LightA-dec 571LR Refurbished Dental LightA-dec 571R Refurbished Dental LightA-dec 572L Dental Light 13 moreA-dec 572LR Refurbished Dental LightA-dec 572R Refurbished Dental LightA-dec 573L Dental LightA-dec 574L Dental LightA-dec 575L Dental LightA-dec 576L Dental LightA-dec 577L Dental LightA-dec 578L Dental LightA-dec Dental Light, 371L Support Center MountA-dec Dental Light, 371LR Refurbished Support Center MountA-dec Dental Light, 372L Radius MountA-dec Dental Light, 372LR Refurbished Radius MountA-dec E72 LED Dental Light | 2011 |
| Dental Belt and/or Gear Driven HandpieceEFA · Class 1 | Dental handpieces | Lister | Air Low Speed HandpieceElectric Low Speed Handpiece | 2021 |
| Ultrasonic ScalerELC · Class 2 | Ultrasonic scalers | Lister | A-dec/W&H ZA-55 Synea Sonic ScalerModule Newtron Can-a EMB | 2010 |
| Saliva Ejector MouthpieceDYN · Class 1 | — | Maker | Saliva Ejector (SE)Saliva Ejector (SE) tip | 2011 |
| Suction Operatory UnitEBR · Class 1 | Suction & evacuation units | Maker | A-dec 362R Support System, RefurbishedA-dec 363R Pedestal MT Support System, RefurbishedA-dec 461R Support System, RefurbishedA-dec 561R Support System, RefurbishedSupport Center/Cuspidor Models:361/362/363/461/561/8200 | 2015 |
| Air and/or Water Syringe UnitECB · Class 1 | Dental hand instruments | Maker | A-dec 200 Dental System - SyringeA-dec Air/Water SyringeA-dec Air/Water Syringe Tip | 2011 |
| Dental Contra- and Right-Angle Attachment HandpieceEGS · Class 1 | Dental handpieces | Lister | Midwest Endo Lit Handpiece | 2026 |
| X-Ray Beam AlignerEHA · Class 1 | — | Maker | Bitewing Viewer | 2015 |
| Oral Cavity EvacuatorEHZ · Class 1 | Suction & evacuation units | Maker | High Volume Evacuator (HVE) Handpiece DurrHigh Volume Evacuator (HVE) including tip11.1370011.1371011.1372011.1373011.13740 | 2020 |
| Ac-Powered Direct Drive HandpieceEKX · Class 1 | Dental handpieces | Lister | Midwest Electric Motor | 2026 |
| Light-Induced Fluorescence Caries DetectorNBL · Class 2 | Caries detection devices | Lister | DIAGNOcam Vision Full HD Intaoral Camera | 2025 |
| Accessories Operative Dental UnitNRD · Class 1 | — | Maker | A-dec DV10plus Dental Dry Vacuum SystemA-dec DV12plus Dental Dry Vacuum SystemA-dec DV5plus Dental Dry Vacuum SystemA-dec DV7plus Dental Dry Vacuum SystemA-dec SC10plus Dental Air CompressorA-dec SC12plus Dental Air CompressorA-dec SC3plus Dental Air CompressorA-dec SC5plus Dental Air CompressorA-dec SC7plus Dental Air CompressorActeon C20 Intraoral Camera | 2019 |
| Dental Chair without Operative UnitNRU · Class 1 | Dental chairs & operative units | Maker | A-dec 311 Dental ChairA-dec 311flt Dental ChairA-dec 311R Refurbished Dental ChairA-dec 311xlc Dental ChairA-dec 317 Specialty Dental ChairA-dec 3460 Porta ChairA-dec 3461 Porta-ChairA-dec 397pb Pediatric BenchA-dec 411 Dental ChairA-dec 411R Refurbished Dental Chair 19 moreA-dec 511 Dental ChairA-dec 511flt Dental ChairA-dec 511R Refurbished Dental ChairA-dec 8000 Performer Dental ChairMonitor Mount 200Monitor Mount 381Monitor Mount 381R, RefurbishedMonitor Mount 382Monitor Mount 382R, RefurbishedMonitor Mount 482Monitor Mount 482R, RefurbishedMonitor Mount 485Monitor Mount 581Monitor Mount 581R, RefurbishedMonitor Mount 584Monitor Mount 585Monitor Mount 586Monitor Mount 587Performer Monitor Mount 8800 | 2014 |
| Light Transmission Caries DetectorNTK · Class 2 | Caries detection devices | Lister | DIAGNOcam Vision Full HD Intaoral Camera | 2025 |
| Intraoral CameraQJK · Class 2 | Intraoral cameras | Lister | Kit,Primescan,ClinicianKit,Primescan,Connection,33X/342Kit,Primescan,Connection,53XKit,Primescan,Connection,541/341 Dr SideKit,Primescan,Connection,Simulator/545/ASSTKit,Primescan,USB Module,Long CableKit,Primescan,USB Module,Short Cable | 2024 |
| Dental Waterline Treatment CartridgeQYJ · Class 1 | — | Lister | A-dec Maintain | 2025 |
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 A-dec, Inc. as the applicant.
| Decided | 510(k) | Device | Device type |
|---|---|---|---|
| 2 Mar 2022 | K213932 | A-dec 300, A-dec 500 | EIA Operative Dental Unit |
| 28 May 2014 | K133776 | A-DEC/W&H ELECTRIC HANDPIECE MOTOR | EBW Handpiece and Cord Foot Controller |
| 24 Nov 2010 | K102234 | A-DEC 200 DENTAL SYSTEM | EIA Operative Dental Unit |
| 9 Jul 2010 | K100647 | A-DEC/W&H SYNEA SONIC SCALER HANDPIECE, MODELS ZA-55, ZA-55 L, ZA-55 LM, ZA-55M, SF1LM | ELC Ultrasonic Scaler |
| 15 Jan 2009 | K082716 | A-DEC/W&H ALEGRA AIR-DRIVEN HIGHSPEED HANDPIECE, MODEL TE-97, TE-98, A-DEC/W&H ALEGRA HANDPIECE ATTACHMENT, MODEL HE-43 | EFB Dental Air-Powered Handpiece |
| 7 Jan 2009 | K082827 | A-DEC/W&H PROFIN RECIPROCATING CONTRA-ANGLE HANDPIECE ATTACHMENT | EFB Dental Air-Powered Handpiece |
| 17 Dec 2008 | K082985 | A-DEC 334/335 DELIVERY SYSTEM | EIA Operative Dental Unit |
| 5 Jul 2007 | K070663 | A-DEC/W&H SYNEA AIR-DRIVEN HIGHSPEED HANDPIECE, MODEL TA-98, TA-97, A-DEC/W&H SYNEA HANDPIECE ATTACHMENT | EFB Dental Air-Powered Handpiece |
| 30 Aug 2005 | K051657 | A-DEC SELF-CONTAINED WATER SYSTEM | EIA Operative Dental Unit |
| 10 Dec 2003 | K032757 | A-DEC SELF-CONTAINED WATER SYSTEM, MODEL 0.7 LITER BOTTLE & 2 LITER BOTTLE | EIA Operative Dental Unit |
| 4 Dec 2003 | K032756 | A-DEC 532/533 DELIVERY SYSTEM MODEL, 532/533 | EIA Operative Dental Unit |
| 3 Dec 2003 | K032572 | A-DEC/W&H ELECTRIC MOTOR, MODEL EA-50LT | EBW Handpiece and Cord Foot Controller |
| 27 Aug 2003 | K032070 | ELCACAM | EIA Operative Dental Unit |
| 5 Oct 2001 | K010127 | W & H ASSISTINA | EFB Dental Air-Powered Handpiece |
| 3 May 2000 | K000968 | 3181 DUO DELIVERY SYSTEM | EIA Operative Dental Unit |
| 3 May 2000 | K000967 | 4635 ASSISTANT'S INSTRUMENTATION | EIA Operative Dental Unit |
| 3 May 2000 | K000966 | 4631 DUO DELIVERY SYSTEM | EIA Operative Dental Unit |
| 11 Jan 2000 | K993526 | SYNEA - LS LOW-SPEED HANDPIECE | EFB Dental Air-Powered Handpiece |
| 10 Sep 1999 | K992011 | SYNEA-HS HIGH SPEED-HANDPIECE | EFB Dental Air-Powered Handpiece |
| 22 Aug 1996 | K962665 | A-DEC SELF-CONTAINED WATER SYSTEM | EIA Operative Dental Unit |
| 25 Mar 1996 | K960506 | A-DEC PERFORMER CONTROL UNIT | EIA Operative Dental Unit |
| 5 Oct 1995 | K945734 | W&H ROTO QUICK COUPLINGS | EFB Dental Air-Powered Handpiece |
| 5 Oct 1995 | K944719 | W&H 100 SERIES LOW SPEED | EFB Dental Air-Powered Handpiece |
| 5 Oct 1995 | K944718 | W&H 900 INCOLIGHT LT HANDPIECE | EFB Dental Air-Powered Handpiece |
| 28 Aug 1995 | K944713 | W&H MICRO AIR MOTOR LT25 | EFB Dental Air-Powered Handpiece |
| 25 Aug 1995 | K944714 | W&H CORSAIR SCALER | EFB Dental Air-Powered Handpiece |
| 25 Aug 1995 | K944712 | W&H MICRO MOTOR E25 (WITHOUT LIGHT) | EFB Dental Air-Powered Handpiece |
| 25 Aug 1995 | K944711 | W&H AIR MOTOR A25 | EFB Dental Air-Powered Handpiece |
| 8 Jun 1995 | K944709 | W&H 896 TOP LIGH HIGHSPEED | EFB Dental Air-Powered Handpiece |
| 2 Jun 1995 | K944717 | W&H 798 TOP AIR TURBINE TRIPLE SPRAY | EFB Dental Air-Powered Handpiece |
| 2 Jun 1995 | K944716 | W&H 796 TOP AIR TURBINE MINI-HEAD | EFB Dental Air-Powered Handpiece |
| 2 Jun 1995 | K944715 | W&H 795 TOP AIR TURBINE SINGLE SPRAY | EFB Dental Air-Powered Handpiece |
| 2 Jun 1995 | K944710 | W&H 898 TOP LIGHT HIGHSPEED | EFB Dental Air-Powered Handpiece |
| 2 Jun 1995 | K944708 | W&H 895 TOP LIGH HIGHSPEED FIBEROPTIC SINGLE SPRAY | EFB Dental Air-Powered Handpiece |
| 12 Jul 1994 | K940893 | A-DEC RADIUS 2122/2132 | EIA Operative Dental Unit |
| 21 Apr 1994 | K935325 | A-DEC CASCADE 3072 WALLMOUNT | EIA Operative Dental Unit |
| 11 Apr 1994 | K925367 | A-DEC 7284 CUSPIDOR, CASCADE | EBR Suction Operatory Unit |
| 31 Jan 1994 | K925119 | A-DEC 1040 CHAIR | KLC Dental Chair with Operative Unit |
| 6 Jan 1994 | K925798 | A-DEC 2545 DUO IC MICRO-CART | EIA Operative Dental Unit |
| 6 Jan 1994 | K925797 | A-DEC 2544 DOCTORS IC MICRO-CART | EIA Operative Dental Unit |
| 9 Dec 1993 | K925325 | A-DEC 2185 DOCTOR'S UNIT | KLC Dental Chair with Operative Unit |
| 9 Dec 1993 | K925324 | A-DEC 2184 DUO UNIT | KLC Dental Chair with Operative Unit |
| 9 Dec 1993 | K925323 | A-DEC 2183 DUO UNIT, CUSP | KLC Dental Chair with Operative Unit |
| 9 Dec 1993 | K925322 | A-DEC 2147 DOCTOR'S UNIT | KLC Dental Chair with Operative Unit |
| 9 Dec 1993 | K925321 | A-DEC 2146 DUO UNIT | KLC Dental Chair with Operative Unit |
| 9 Dec 1993 | K925320 | A-DEC 2145 DUO UNIT, CUSP | KLC Dental Chair with Operative Unit |
| 9 Dec 1993 | K925319 | A-DEC 2182 DOCTOR'S UNIT | KLC Dental Chair with Operative Unit |
| 9 Dec 1993 | K925318 | A-DEC 2181 DUO UNIT | KLC Dental Chair with Operative Unit |
| 9 Dec 1993 | K925317 | A-DEC 2180 DUO UNIT, CUSP | KLC Dental Chair with Operative Unit |
| 9 Dec 1993 | K925316 | A-DEC 2172 DOCTOR'S UNIT | KLC Dental Chair with Operative Unit |
| 9 Dec 1993 | K925315 | A-DEC 2171 DUO UNIT | KLC Dental Chair with Operative Unit |
| 9 Dec 1993 | K925314 | A-DEC 2170 DUO UNIT CUSP | KLC Dental Chair with Operative Unit |
| 29 Nov 1993 | K931137 | DENTAL SYRINGE TIP | ECB Air and/or Water Syringe Unit |
| 20 Oct 1993 | K933166 | A-DEC 2611 ASSISTANT'S CART | EIA Operative Dental Unit |
| 13 Oct 1993 | K933167 | A-DEC 2912 DUO CART | EIA Operative Dental Unit |
| 12 Oct 1993 | K933168 | A-DEC 3127 ASSISTANT'S WALLMOUNT | EIA Operative Dental Unit |
| 12 Oct 1993 | K933165 | A-DEC 3131 DUO WALLMOUNT (WITH INSTRUMENTATION) | EIA Operative Dental Unit |
| 12 Oct 1993 | K933163 | A-DEC 2612 ASSISTANT'S CART | EIA Operative Dental Unit |
| 9 Oct 1991 | K913535 | A-DEC DECADE 1020 CHAIR | KLC Dental Chair with Operative Unit |
| 8 Oct 1991 | K913059 | A-DEC KNEEBREAK 1030 CHAIR | KLC Dental Chair with Operative Unit |
| 24 Oct 1990 | K903455 | A-DEC DECADE CUSPIDOR | EIA Operative Dental Unit |
| 24 Oct 1990 | K903454 | A-DEC DECADE 1010 CHAIR | KLC Dental Chair with Operative Unit |
| 24 Oct 1990 | K903453 | A-DEC IC MICRO-CART | EIA Operative Dental Unit |
| 24 Oct 1990 | K903452 | A-DEC IC CONTROL HEAD | EIA Operative Dental Unit |
| 24 Oct 1990 | K903451 | A-DEC PAC I PORTABLE UNIT | EIA Operative Dental Unit |
| 24 Oct 1990 | K903450 | A-DEC DECADE 1015 CHAIR | KLC Dental Chair with Operative Unit |
| 14 Jul 1989 | K893045 | A-DEC PRIORITY 1005 CHAIR | KLC Dental Chair with Operative Unit |
| 14 Jul 1989 | K893044 | A-DEC DENTAL LIGHT | EAZ Dental Operating Light |
Some of these clearances are listed with FDA today by another company: Gebr. Brasseler GmbH & Co. KG (1).
Also lists devices cleared under other names
A-dec, 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: Kaltenbach & Voigt GmbH (4), Dentsply Sirona, Inc. (3), Sybron Dental Specialties (2), Nsk Nakanishi, Inc. (2), Satelec - Acteon Group (1), Nakanishi, Inc. (1), Kaltenbach & Voigt Gmgh (1), W&H Dentalwerk Bürmoos GmbH (1).
| Decided | 510(k) | Device | Applicant | Device type |
|---|---|---|---|---|
| 25 Aug 2025 | K251811 | Motor and Apex Module (MaAM) | Dentsply Sirona, Inc. | EBW Handpiece and Cord Foot Controller |
| 11 Mar 2024 | K233922 | SP NEWTRON CAN-A; MODULE NEWTRON CAN-A EMB; SUPPORT XINETIC; NWT CAN SLIM LED CORD G3 SHORT; NWT CAN SLIM LED CORD G3 LONG | Satelec - Acteon Group | ELC Ultrasonic Scaler |
| 23 Nov 2019 | K182712 | DEXIS CariVu 3-in-1 by KaVo | Kaltenbach & Voigt GmbH | NTK Light Transmission Caries Detector |
| 11 May 2017 | K163131 | A-dec NLZ Electric Motor System | Nakanishi, Inc. | EBW Handpiece and Cord Foot Controller |
| 17 Mar 2017 | K163239 | SMARTmatic | Kaltenbach & Voigt GmbH | EFA Dental Belt and/or Gear Driven Handpiece |
| 21 Feb 2017 | K163317 | ELECTROmatic | Kaltenbach & Voigt Gmgh | EBW Handpiece and Cord Foot Controller |
| 23 Nov 2016 | K161957 | W&H Implantmed SI-1015 incl. Accessories | W&H Dentalwerk Bürmoos GmbH | EBW Handpiece and Cord Foot Controller |
| 2 Jul 2015 | K150750 | Endo 6:1, T1 Line Endo 6 L, SIRONiTi Apex, T1 Spray | Dentsply Sirona, Inc. | EGS Dental Contra- and Right-Angle Attachment Handpiece |
| 9 Apr 2015 | K143465 | MASTERmatic LUX | Kaltenbach & Voigt GmbH | EFA Dental Belt and/or Gear Driven Handpiece |
| 30 May 2014 | K131319 | T1/T2/T3 TURBINE FAMILY | Dentsply Sirona, Inc. | EFB Dental Air-Powered Handpiece |
| 27 Sep 2013 | K130560 | MASTERTORQUE LUX 8900 L | Kaltenbach & Voigt GmbH | EFB Dental Air-Powered Handpiece |
| 5 Apr 2010 | K093341 | CENTURY MODEL 105C | Sybron Dental Specialties | EFB Dental Air-Powered Handpiece |
| 24 Jul 2009 | K090937 | E-STATIS 40 SYSTEM | Coltene/Whaledent AG | EBW Handpiece and Cord Foot Controller |
| 3 Sep 2008 | K073478 | SUPERTORQUE HIGH-SPEED HANDPIECES AND GENTLEPOWER HANDPIECES AND ATTACHEMENTS | Sybron Dental Specialties | EFB Dental Air-Powered Handpiece |
| 9 Jun 1999 | K990954 | ELEC-MATE, MODELS EX-6 SET, EX-6L SET, EX-30 SET | Nsk Nakanishi, Inc. | EBW Handpiece and Cord Foot Controller |
| 10 Dec 1998 | K983183 | GYRO LONG-LIFE,BLACK PEARL ECO, ONDINE &CROMA, PRESTIGE, BORA, AQUILON, MC2,MC3, BASCH, ISOLITE, OPTIMA, US, PLPE, CA, P | Bien Air USA, Inc. | EFB Dental Air-Powered Handpiece |
| 22 Sep 1997 | K972436 | T1 LINE DENTAL HANDPIECES | Siemens AG | EFB Dental Air-Powered Handpiece |
| 24 Sep 1996 | K962542 | AIR MOTOR HANDPIECE TN-102 | Nsk Nakanishi, Inc. | EFB Dental Air-Powered Handpiece |
Registered establishments
| Establishment | Location | What it does |
|---|---|---|
| A-dec, Inc.FDA reg. 3015729 | Newberg, OR, United States | Complaint file establishment, Manufacturer, Repacker / relabeler, Specification developer |
Sources
FDA establishment registration & device listing (search FDA, owner/operator 10023499). 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.