Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3015729

FEI Number

3015729

Entity Name

A-dec, Inc.

City/State/Country

Newberg, OR, US

Establishment Address

2601 Crestview Drive, Newberg, OR 97132, US

Establishment Type(s)

Complaint File Establishment per 21 CFR 820.198

Owner / Operator

A-dec, Inc. (Owner Number: 10023499)

Owner / Operator Contact Address

2601 Crestview Drive, Newberg, OR 97132, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K161957

PMA Number

N/A

All Registered Proprietary Names

Midwest Implant Handpiece Bitewing Viewer Kit,Primescan,Connection,53X Kit,Primescan,Connection,541/341 Dr Side Kit,Primescan,USB Module,Long Cable Kit,Primescan,Connection,Simulator/545/ASST Kit,Primescan,Clinician Kit,Primescan,Connection,33X/342 Kit,Primescan,USB Module,Short Cable A-dec Air/Water Syringe A-dec 200 Dental System - Syringe A-dec Air/Water Syringe Tip Delivery System A-dec 500 Assistant's Instrumentation Refurbished Assistant's Instrumentation Refurbished Delivery System Electric Low Speed Handpiece A-dec Dental Face Shield A-dec Maintain Radius/Cascade Decade A-dec 200, 300, 400, 500 Performer Self-Contained Water System (with ICX as accessory) DIAGNOcam Vision Full HD Intaoral Camera 3181 Duo Delivery System Saliva Ejector (SE) tip Saliva Ejector (SE) A-dec 300pro Delivery Systems A-dec 500sta Assistant's Instrumentation A-dec 341sp Specialty Delivery System A-dec 500pro Delivery Systems A-dec 300pro Cart Delivery System 4631 Duo Delivery System Electric Motor Assistina Maintenance System Air Low Speed Handpiece 4635 Assistants Instrumentation A-dec DV7plus Dental Dry Vacuum System A-dec SC5plus Dental Air Compressor A-dec DV5plus Dental Dry Vacuum System A-dec DV10plus Dental Dry Vacuum System A-dec SC10plus Dental Air Compressor A-dec SC12plus Dental Air Compressor A-dec SC3plus Dental Air Compressor A-dec SC7plus Dental Air Compressor Acteon C20 Intraoral Camera A-dec DV12plus Dental Dry Vacuum System High Speed Handpieces High Speed Handpieces A-dec S76 Surgical Light Performer Assistant's Instrumentation 8500 Performer Performer Delivery System 8100 A-dec 577L Dental Light A-dec 570L LED Retrofit A-dec 573L Dental Light A-dec 575L Dental Light A-dec 578L Dental Light A-dec 576L Dental Light A-dec 574L Dental Light A-dec 571L Dental Light A-dec 572L Dental Light A-dec 571R Refurbished Dental Light A-dec 572LR Refurbished Dental Light A-dec 571LR Refurbished Dental Light A-dec 572R Refurbished Dental Light NLX Nano NLX Plus Electric Motor 11.13740 11.13700 11.13730 High Volume Evacuator (HVE) including tip 11.13720 11.13710 High Volume Evacuator (HVE) Handpiece Durr A-dec Dental Light, 371L Support Center Mount A-dec Dental Light, 372L Radius Mount A-dec 375L LED Dental Lt, Wall/Side Cabinet Mt A-dec 377L LED Dental Lt, Track Mt A-dec 374L LED Dental Lt, Central Cabinet Mt A-dec 376L LED Dental Lt, Ceiling Mt A-dec 378L LED Dental Lt, Simulator Mt A-dec Dental Light, 372LR Refurbished Radius Mount A-dec Dental Light, 371LR Refurbished Support Center Mount A-dec E72 LED Dental Light A-dec XC10 Electric Motor A-dec/W&H ZA-55 Synea Sonic Scaler Lisa Steam Sterilizer Midwest Electric Motor Midwest Endo Lit Handpiece Implant Sterile Tubing Module Newtron Can-a EMB Electric Motor EA-40LT EA-30 EA-52LED EA-51LT EA-50LT AM-5 SD AM-20RM AM-20 SD AM-20 MW AM-5 MW Micro Air Motors: Motor Controller

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
EFB	Handpiece, Air-Powered, Dental	Dental	Class 1	872.4200	2026-02-12
EHA	Aligner, Beam, X-Ray	Dental	Class 1	872.1820	2015-10-27
QJK	Intraoral Camera	Dental	Class 2	872.3661	2024-07-23
ECB	Unit, Syringe, Air And/Or Water	Dental	Class 1	872.4565	2011-06-13
EIA	Unit, Operative Dental	Dental	Class 1	872.6640	2007-11-27
EFA	Handpiece, Belt And/Or Gear Driven, Dental	Dental	Class 1	872.4200	2021-05-26
LYU	Accessory, Surgical Apparel	General, Plastic Surgery	Class 1	878.4040	2020-06-03
QYJ	Dental Waterline Treatment Cartridge	Dental	Class 1	872.6640	2025-09-10
EIA	Unit, Operative Dental	Dental	Class 1	872.6640	2007-11-27
NTK	Caries Detector, Laser Light, Transmission	Dental	Class 2	872.1745	2025-01-30
NBL	Laser, Fluorescence Caries Detection	Dental	Class 2	872.1745	2025-01-30
EIA	Unit, Operative Dental	Dental	Class 1	872.6640	2007-11-27
DYN	Mouthpiece, Saliva Ejector	Dental	Class 1	872.6640	2011-06-13
EIA	Unit, Operative Dental	Dental	Class 1	872.6640	2023-03-13
EIA	Unit, Operative Dental	Dental	Class 1	872.6640	2007-11-27
EBW	Controller, Foot, Handpiece And Cord	Dental	Class 1	872.4200	2021-05-24
EFB	Handpiece, Air-Powered, Dental	Dental	Class 1	872.4200	2007-11-27
EFA	Handpiece, Belt And/Or Gear Driven, Dental	Dental	Class 1	872.4200	2021-05-26
EIA	Unit, Operative Dental	Dental	Class 1	872.6640	2007-11-27
NRD	Unit, Operative Dental, Accessories	Dental	Class 1	872.6640	2019-10-22
EFB	Handpiece, Air-Powered, Dental	Dental	Class 1	872.4200	2021-06-07
EFB	Handpiece, Air-Powered, Dental	Dental	Class 1	872.4200	2021-06-02
FTD	Lamp, Surgical	General, Plastic Surgery	Class 2	878.4580	2026-05-04
EIA	Unit, Operative Dental	Dental	Class 1	872.6640	2007-11-27
EAZ	Light, Operating, Dental	Dental	Class 1	872.4630	2011-06-13
EBW	Controller, Foot, Handpiece And Cord	Dental	Class 1	872.4200	2020-07-06
EHZ	Evacuator, Oral Cavity	Dental	Class 1	872.6640	2020-05-28
EAZ	Light, Operating, Dental	Dental	Class 1	872.4630	2017-04-10
EBW	Controller, Foot, Handpiece And Cord	Dental	Class 1	872.4200	2024-10-29
ELC	Scaler, Ultrasonic	Dental	Class 2	872.4850	2010-12-08
FLE	Sterilizer, Steam	General Hospital	Class 2	880.6880	2007-11-27
EKX	Handpiece, Direct Drive, Ac-Powered	Dental	Class 1	872.4200	2026-01-15
EBW	Controller, Foot, Handpiece And Cord	Dental	Class 1	872.4200	2026-01-15
LQY	Locator, Root Apex	Unknown	Class U	N/A	2026-01-15
EGS	Handpiece, Contra- And Right-Angle Attachment, Dental	Dental	Class 1	872.4200	2026-02-12
EFB	Handpiece, Air-Powered, Dental	Dental	Class 1	872.4200	2026-02-12
ELC	Scaler, Ultrasonic	Dental	Class 2	872.4850	2025-04-30
LRJ	Disinfectant, Medical Devices	General Hospital	Class 1	880.6890	2021-11-17
EBW	Controller, Foot, Handpiece And Cord	Dental	Class 1	872.4200	2020-07-06
EBW	Controller, Foot, Handpiece And Cord	Dental	Class 1	872.4200	2007-11-27
EFB	Handpiece, Air-Powered, Dental	Dental	Class 1	872.4200	2007-11-27
EBW	Controller, Foot, Handpiece And Cord	Dental	Class 1	872.4200	2019-04-03

Official Correspondent

Rafael Vasquez-Villa

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

A-dec, 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
K212910	Shenzhen Carejoy Technology Co., Ltd.	Dental High-speed Turbine Handpiece, Dental Low-speed Turbine Handpiece	2022-11-17
K781592	Henry Schein, Inc.	SURGICAL ASPIRATOR TIPS	1978-12-04
K040153	Indigenous Peoples Technology and Education Center	I-TEC PORTABLE DENTAL OPERATORY	2004-05-21
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

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3015729. Last updated year: 2026. Please use registration number 3015729 when referencing this establishment in official correspondence.