510(k) Report

FDA applicant

A-Dec, Inc.

Newberg, OR69 decisions1989–20221 recall

FDA records 69 decisions for A-Dec, Inc. (Newberg, OR) from 1989 to 2022: 69 510(k) clearances. Most are in product codes EIA (Unit, Operative Dental) and EFB (Handpiece, Air-Powered, Dental). Its devices cite 1 predicate, 1 of them its own earlier devices. 1 recall is linked to its devices.

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly, last Nov 3, 2026

FIG. A — Illustration, dental panel, where it files most

How often FDA has decided A-Dec, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

1in 2022

2007: 12008: 12009: 22010: 22014: 12022: 1
2007high 2 (2009) · low 0 (2011)2026

2026 so far, outlined.

Recalls per year

1in 2009

2009: 1
2007high 1 (2009) · low 0 (2007)2026

Class I Class II/III not classified

FIG. 1 — A-Dec, Inc. by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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Which product codes does it file in?

  • EIAUnit, Operative Dental25decisions
  • EFBHandpiece, Air-Powered, Dental19decisions
  • KLCChair, Dental, With Operative Unit18decisions
  • EBWController, Foot, Handpiece And Cord2decisions
  • ELCScaler, Ultrasonic1decision
  • ECBUnit, Syringe, Air And/Or Water1decision

Also: FLE (1), EAZ (1), EBR (1).

Who builds on its devices?

Later devices cite its devices 44 times; 1 of those are its own. The firms that cite it most:

Which of its devices are cited most?

Its devices that later submissions most often claim equivalence to.

  • K070663A-Dec/W&H Synea Air-Driven Highspeed Handpiece, Model TA-98, TA-97, a-Dec/W&H Synea Handpiece AttachmentA-Dec, Inc. · 20077cite it
  • K102234A-Dec 200 Dental SystemA-Dec, Inc. · 20104cite it
  • K082827A-Dec/W&H Profin Reciprocating Contra-Angle Handpiece AttachmentA-Dec, Inc. · 20094cite it
  • K993526Synea - LS Low-Speed HandpieceA-Dec, Inc. · 20004cite it
  • K962665A-Dec Self-Contained Water SystemA-Dec, Inc. · 19963cite it
  • K010127W & H AssistinaA-Dec, Inc. · 20013cite it

What has FDA decided for it lately?

  • K213932A-dec 300, A-dec 500A-Dec, Inc. · 2022
  • K133776A-Dec/W&H Electric Handpiece MotorA-Dec, Inc. · 2014
  • K102234A-Dec 200 Dental SystemA-Dec, Inc. · 2010
  • K100647A-Dec/W&H Synea Sonic Scaler Handpiece, Models ZA-55, ZA-55 L, ZA-55 LM, ZA-55M, SF1LMA-Dec, Inc. · 2010
  • K082716A-Dec/W&H Alegra Air-Driven Highspeed Handpiece, Model TE-97, TE-98, a-Dec/W&H Alegra Handpiece Attachment…A-Dec, Inc. · 2009
  • K082827A-Dec/W&H Profin Reciprocating Contra-Angle Handpiece AttachmentA-Dec, Inc. · 2009
  • K082985A-Dec 334/335 Delivery SystemA-Dec, Inc. · 2008
  • K070663A-Dec/W&H Synea Air-Driven Highspeed Handpiece, Model TA-98, TA-97, a-Dec/W&H Synea Handpiece AttachmentA-Dec, Inc. · 2007

All 69 as A-Dec, Inc. →

What has been recalled?

1 recall linked to its devices; the latest:

  • K913535A-dec Decade Plus 1221 Dental Chair This chair is used for positioning dental patient…Apr 1, 2009