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Data / Medical devices / United States / A-dec, Inc.

A-dec, Inc.: FDA-registered device maker in Newberg, OR, United States, 39 510(k) clearances

A-dec, Inc. is registered with the FDA (registration 3015729) in Newberg, OR, United States. It lists 24 device types. The FDA files 39 510(k) clearances under its listings, the newest dated August 25, 2025. 1 recall event names it as the recalling firm. Registered through 2026. FDA data exported November 2, 2026.

SpecStream is the live web data engine for teams and agents. It reads the FDA registration and listing, 510(k), PMA, recall and enforcement files from openFDA every week, and this page is that reading, joined by the FDA's own numbers. Ask for the makers of any device type in any country and new clearances, approvals and recalls arrive in your sheet, CRM, Slack or agent as the FDA publishes them.

Get makers like this oneWatch A-dec, Inc.
FDA registration number
3015729
Address
2601 Crestview Drive, Newberg, OR, United States, 97132
Owner or operator
A-dec, Inc. (10023499)
Roles
Complaint file establishment, Manufacturer, Repackager or relabeler, Specification developer
First device listed
November 27, 2007
Registered through
2026
Brand names listed
11.13700, 11.13710, 11.13720, 11.13730, 11.13740, 3181 Duo Delivery System, 4631 Duo Delivery System, 4635 Assistants Instrumentation and more

Devices it lists

DeviceProduct codeClassRoleSource
Accessory, Surgical ApparelLYU1Manufactureraccessdata.fda.gov
Aligner, Beam, X-RayEHA1Manufactureraccessdata.fda.gov
Chair, Dental, Without Operative UnitNRU1Manufacturer, Specification developeraccessdata.fda.gov
Controller, Foot, Handpiece And CordEBW1Complaint file establishment, Manufacturer, Repackager or relabeleraccessdata.fda.gov
Dental Waterline Treatment CartridgeQYJ1Repackager or relabeleraccessdata.fda.gov
Disinfectant, Medical DevicesLRJ1Complaint file establishment, Specification developeraccessdata.fda.gov
Evacuator, Oral CavityEHZ1Manufacturer, Repackager or relabeleraccessdata.fda.gov
Handpiece, Air-Powered, DentalEFB1Complaint file establishment, Repackager or relabeleraccessdata.fda.gov
Handpiece, Belt And/Or Gear Driven, DentalEFA1Repackager or relabeleraccessdata.fda.gov
Handpiece, Contra- And Right-Angle Attachment, DentalEGS1Repackager or relabeleraccessdata.fda.gov
Handpiece, Direct Drive, Ac-PoweredEKX1Complaint file establishment, Repackager or relabeleraccessdata.fda.gov
Intraoral CameraQJK2Repackager or relabeleraccessdata.fda.gov
Lamp, SurgicalFTD2Complaint file establishment, Repackager or relabeleraccessdata.fda.gov
Light Transmission Caries DetectorNTK2Repackager or relabeleraccessdata.fda.gov
Light, Operating, DentalEAZ1Complaint file establishment, Manufacturer, Repackager or relabeleraccessdata.fda.gov
Light-Induced Fluorescence Caries Detector NBL2Repackager or relabeleraccessdata.fda.gov
Locator, Root ApexLQYUComplaint file establishment, Repackager or relabeleraccessdata.fda.gov
Mouthpiece, Saliva EjectorDYN1Manufactureraccessdata.fda.gov
Scaler, UltrasonicELC2Repackager or relabeleraccessdata.fda.gov
Sterilizer, SteamFLE2Repackager or relabeleraccessdata.fda.gov
Unit, Operative DentalEIA1Complaint file establishment, Manufacturer, Specification developeraccessdata.fda.gov
Unit, Operative Dental, AccessoriesNRD1Manufactureraccessdata.fda.gov
Unit, Suction OperatoryEBR1Manufactureraccessdata.fda.gov
Unit, Syringe, Air And/Or WaterECB1Manufacturer, Repackager or relabeleraccessdata.fda.gov

510(k) clearances

The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.

Decided510(k) numberDeviceProduct codeDecisionApplicantSource
August 25, 2025K251811Motor and Apex Module (MaAM)EBWSubstantially EquivalentDentsply Sirona, Inc.accessdata.fda.gov
March 11, 2024K233922SP NEWTRON CAN-A; MODULE NEWTRON CAN-A EMB; SUPPORT XINETIC; NWT CAN SLIM LED CORD G3 SHORT; NWT CAN SLIM LED CORD G3 LONGELCSubstantially EquivalentSatelec - Acteon Groupaccessdata.fda.gov
March 2, 2022K213932A-dec 300, A-dec 500EIASubstantially EquivalentA-Dec, Inc.accessdata.fda.gov
November 23, 2019K182712DEXIS CariVu 3-in-1 by KaVoNTKSubstantially EquivalentKaltenbach & Voigt GmbHaccessdata.fda.gov
May 11, 2017K163131A-dec NLZ Electric Motor SystemEBWSubstantially EquivalentNakanishi, Inc.accessdata.fda.gov
March 17, 2017K163239SMARTmaticEFASubstantially EquivalentKaltenbach & Voigt GmbHaccessdata.fda.gov
February 21, 2017K163317ELECTROmaticEBWSubstantially EquivalentKaltenbach & Voigt Gmghaccessdata.fda.gov
November 23, 2016K161957W&H Implantmed SI-1015 incl. AccessoriesEBWSubstantially EquivalentW&H Dentalwerk Burmoos GmbHaccessdata.fda.gov
July 2, 2015K150750Endo 6:1, T1 Line Endo 6 L, SIRONiTi Apex, T1 SprayEGSSubstantially EquivalentSirona Dental Systems GmbHaccessdata.fda.gov
April 9, 2015K143465MASTERmatic LUXEFASubstantially EquivalentKaltenbach & Voigt GmbHaccessdata.fda.gov
May 30, 2014K131319T1/T2/T3 TURBINE FAMILYEFBSubstantially EquivalentSirona Dental Systems GmbHaccessdata.fda.gov
May 28, 2014K133776A-DEC/W&H ELECTRIC HANDPIECE MOTOREBWSubstantially EquivalentA-Dec, Inc.accessdata.fda.gov
September 27, 2013K130560MASTERTORQUE LUX 8900 LEFBSubstantially EquivalentKaltenbach & Voigt GmbHaccessdata.fda.gov
November 24, 2010K102234A-DEC 200 DENTAL SYSTEMEIASubstantially EquivalentA-Dec, Inc.accessdata.fda.gov
July 9, 2010K100647A-DEC/W&H SYNEA SONIC SCALER HANDPIECE, MODELS ZA-55, ZA-55 L, ZA-55 LM, ZA-55M, SF1LMELCSubstantially EquivalentA-Dec, Inc.accessdata.fda.gov
April 5, 2010K093341CENTURY MODEL 105CEFBSubstantially EquivalentSybron Dental Specialties, Inc.accessdata.fda.gov
July 24, 2009K090937E-STATIS 40 SYSTEMEBWSubstantially EquivalentScican , Ltd.accessdata.fda.gov
December 17, 2008K082985A-DEC 334/335 DELIVERY SYSTEMEIASubstantially EquivalentA-Dec, Inc.accessdata.fda.gov
September 3, 2008K073478SUPERTORQUE HIGH-SPEED HANDPIECES AND GENTLEPOWER HANDPIECES AND ATTACHEMENTSEFBSubstantially EquivalentSybron Dental Specialties, Inc.accessdata.fda.gov
July 5, 2007K070663A-DEC/W&H SYNEA AIR-DRIVEN HIGHSPEED HANDPIECE, MODEL TA-98, TA-97, A-DEC/W&H SYNEA HANDPIECE ATTACHMENTEFBSubstantially EquivalentA-Dec, Inc.accessdata.fda.gov
August 30, 2005K051657A-DEC SELF-CONTAINED WATER SYSTEMEIASubstantially EquivalentA-Dec, Inc.accessdata.fda.gov
December 4, 2003K032756A-DEC 532/533 DELIVERY SYSTEM MODEL, 532/533EIASubstantially EquivalentA-Dec, Inc.accessdata.fda.gov
December 3, 2003K032572A-DEC/W&H ELECTRIC MOTOR, MODEL EA-50LTEBWSubstantially EquivalentA-Dec, Inc.accessdata.fda.gov
February 7, 2003K022816W & H LISA STEAM STERILIZERFLESubstantially EquivalentA-Dec, Inc.accessdata.fda.gov
October 5, 2001K010127W & H ASSISTINAEFBSubstantially EquivalentA-Dec, Inc.accessdata.fda.gov
May 3, 2000K0009683181 DUO DELIVERY SYSTEMEIASubstantially EquivalentA-Dec, Inc.accessdata.fda.gov
May 3, 2000K0009674635 ASSISTANT'S INSTRUMENTATIONEIASubstantially EquivalentA-Dec, Inc.accessdata.fda.gov
May 3, 2000K0009664631 DUO DELIVERY SYSTEMEIASubstantially EquivalentA-Dec, Inc.accessdata.fda.gov
June 9, 1999K990954ELEC-MATE, MODELS EX-6 SET, EX-6L SET, EX-30 SETEBWSubstantially EquivalentNsk Nakanishi, Inc.accessdata.fda.gov
December 10, 1998K983183GYRO LONG-LIFE,BLACK PEARL ECO, ONDINE &CROMA, PRESTIGE, BORA, AQUILON, MC2,MC3, BASCH, ISOLITE, OPTIMA, US, PLPE, CA, PEFBSubstantially EquivalentBien Air USA, Inc.accessdata.fda.gov
September 22, 1997K972436T1 LINE DENTAL HANDPIECESEFBSubstantially EquivalentSiemens AGaccessdata.fda.gov
September 24, 1996K962542AIR MOTOR HANDPIECE TN-102EFBSubstantially EquivalentNsk Nakanishi, Inc.accessdata.fda.gov
March 25, 1996K960506A-DEC PERFORMER CONTROL UNITEIASubstantially EquivalentA-Dec, Inc.accessdata.fda.gov
August 28, 1995K944713W&H MICRO AIR MOTOR LT25EFBSubstantially EquivalentA-Dec, Inc.accessdata.fda.gov
August 25, 1995K944711W&H AIR MOTOR A25EFBSubstantially EquivalentA-Dec, Inc.accessdata.fda.gov
January 6, 1994K925797A-DEC 2544 DOCTORS IC MICRO-CARTEIASubstantially EquivalentA-Dec, Inc.accessdata.fda.gov
November 29, 1993K931137DENTAL SYRINGE TIPECBSubstantially EquivalentA-Dec, Inc.accessdata.fda.gov
October 24, 1990K903451A-DEC PAC I PORTABLE UNITEIASubstantially EquivalentA-Dec, Inc.accessdata.fda.gov
July 14, 1989K893044A-DEC DENTAL LIGHTEAZSubstantially EquivalentA-Dec, Inc.accessdata.fda.gov

Recalls

Recall events where this establishment is the recalling firm, matched on its FEI.

InitiatedEventClassStatusProductReasonSource
April 1, 200952039Not yet classifiedTerminatedA-dec Decade Plus 1221 Dental Chair This chair is used for positioning dental patient prior to and during dental treatment.The design of the Decade Plus 1221 chair backrest creates a possible pinch-point between the chair backrest and the underside of the armrests.accessdata.fda.gov

Compare with other makers

Updated August 25, 2025. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.