FDA Registration
Active
🇺🇸 United States
A-dec, Inc.
Reg #: 3015729
·
FEI: 3015729
·
Expires 2026
Products
24
Proprietary Names
160
Establishment Types
4
Classifications
24
Registration Details
- Registration Name
- A-dec, Inc.
- Registration Number
- 3015729
- FEI Number
- 3015729
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- Yes
- Address
- 2601 Crestview Drive
- City
- Newberg
- State
- OR
- ZIP
- 97132
- Country
- US
Regulatory Submissions
- 510(k) Number
- K983183
Owner / Operator
- Firm Name
- A-dec, Inc.
- Operator Number
- 10023499
- Address
- 2601 Crestview Drive
- City
- Newberg
- State
- OR
- Postal Code
- 97132
- Country
- US
- Correspondent
- Rafael A Vasquez-Villa
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Handpiece, Air-Powered, Dental | EFB | Class 1 | Dental | No | 2026-02-12 |
| Aligner, Beam, X-Ray | EHA | Class 1 | Dental | No | 2015-10-27 |
| Intraoral Camera | QJK | Class 2 | Dental | No | 2024-07-23 |
| Unit, Syringe, Air And/Or Water | ECB | Class 1 | Dental | No | 2011-06-13 |
| Unit, Operative Dental | EIA | Class 1 | Dental | No | 2007-11-27 |
| Handpiece, Belt And/Or Gear Driven, Dental | EFA | Class 1 | Dental | No | 2021-05-26 |
| Accessory, Surgical Apparel | LYU | Class 1 | General, Plastic Surgery | No | 2020-06-03 |
| Dental Waterline Treatment Cartridge | QYJ | Class 1 | Dental | No | 2025-09-10 |
| Caries Detector, Laser Light, Transmission | NTK | Class 2 | Dental | No | 2025-01-30 |
| Laser, Fluorescence Caries Detection | NBL | Class 2 | Dental | No | 2025-01-30 |
| Mouthpiece, Saliva Ejector | DYN | Class 1 | Dental | No | 2011-06-13 |
| Controller, Foot, Handpiece And Cord | EBW | Class 1 | Dental | No | 2021-05-24 |
| Unit, Operative Dental, Accessories | NRD | Class 1 | Dental | No | 2019-10-22 |
| Lamp, Surgical | FTD | Class 2 | General, Plastic Surgery | No | 2026-05-04 |
| Light, Operating, Dental | EAZ | Class 1 | Dental | No | 2011-06-13 |
| Evacuator, Oral Cavity | EHZ | Class 1 | Dental | No | 2020-05-28 |
| Scaler, Ultrasonic | ELC | Class 2 | Dental | No | 2010-12-08 |
| Sterilizer, Steam | FLE | Class 2 | General Hospital | No | 2007-11-27 |
| Handpiece, Direct Drive, Ac-Powered | EKX | Class 1 | Dental | No | 2026-01-15 |
| Locator, Root Apex | LQY | Class U | Unknown | No | 2026-01-15 |
| Handpiece, Contra- And Right-Angle Attachment, Dental | EGS | Class 1 | Dental | No | 2026-02-12 |
| Disinfectant, Medical Devices | LRJ | Class 1 | General Hospital | No | 2021-11-17 |
| Chair, Dental, Without Operative Unit | NRU | Class 1 | Dental | No | 2014-11-19 |
| Unit, Suction Operatory | EBR | Class 1 | Dental | No | 2015-10-26 |
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
A-dec S76 Surgical Light
Performer Assistant's Instrumentation 8500
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
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
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
Midwest Endo Unlit Handpiece
A-dec 300
Air High Speed Handpieces
Synea
Roto-Quick
Trend
Alegra
EA-53
EA-53TT
A-dec 200 Dental Delivery System
A-dec 200 Dental Chair
A-dec 200 Support Center, Cuspidor, Assistant's Instrumentation
A-dec 200 Dental Light
Decade 2562 Doctor's Cart
Decade 2561 Duo Cart
Cascade 2615 Assistant's Cart
Cascade 2671 Due Cart Deliver System
Micro Air Motor LT25
Micro Air Motor A-25LT
A-dec 8000 Performer Dental Chair
Monitor Mount 382
A-dec 3460 Porta Chair
Monitor Mount 485
Monitor Mount 584
Monitor Mount 581
Monitor Mount 587
A-dec 511 Dental Chair
Monitor Mount 585
A-dec 311 Dental Chair
Performer Monitor Mount 8800
Monitor Mount 482
Monitor Mount 586
A-dec 411 Dental Chair
Monitor Mount 381
Monitor Mount 200
A-dec 511R Refurbished Dental Chair
Monitor Mount 382R, Refurbished
A-dec 311R Refurbished Dental Chair
A-dec 411R Refurbished Dental Chair
A-dec 3461 Porta-Chair
A-dec 311flt Dental Chair
Monitor Mount 482R, Refurbished
A-dec 311xlc Dental Chair
A-dec 511flt Dental Chair
A-dec 397pb Pediatric Bench
Monitor Mount 581R, Refurbished
A-dec 317 Specialty Dental Chair
Monitor Mount 381R, Refurbished
Pac 1 3420 Field Unit
Pac 1 3420 Self-Contained Unit
Pac 1 3420 Institutional Unit
Support Center/Cuspidor Models:361/362/363/461/561/8200
A-dec 461R Support System, Refurbished
A-dec 561R Support System, Refurbished
A-dec 363R Pedestal MT Support System, Refurbished
A-dec 362R Support System, Refurbished
Establishment Types
Repack or Relabel Medical Device
Manufacture Medical Device
Complaint File Establishment per 21 CFR 820.198
Develop Specifications But Do Not Manufacture At This Facility