510(k) Report

FDA applicant

3M Unitek

Monrovia, CA9 decisions1995–20170 recalls

FDA records 9 decisions for 3M Unitek (Monrovia, CA) from 1995 to 2017: 9 510(k) clearances. Most are in product codes DYH (Adhesive, Bracket And Tooth Conditioner, Resin) and NJM (Bracket, Ceramic, Orthodontic). Its devices cite 8 predicates, 1 of them its own earlier devices. No recall is linked to its devices.

FDA’s records also spell it “3M Unitek Corporation”.

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 3M Unitek’s devices, and how often a recall has named them.

FDA decisions per year

1in 2017

2008: 12010: 12011: 12012: 12017: 1
2007high 1 (2008) · low 0 (2007)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — 3M Unitek by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like 3M Unitek’s? A 510(k) Report ranks candidate predicates for your device by lineage, citations and recall history, with the review-time outlook.

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Which product codes does it file in?

  • DYHAdhesive, Bracket And Tooth Conditioner, Resin6decisions
  • NJMBracket, Ceramic, Orthodontic2decisions
  • NXCAligner, Sequential1decision

Whose devices does it build on?

Its devices cite 8 predicates; 1 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 21 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.

  • K102803Clarity Advanced Ceramic Brackets3M Unitek Corporation · 20117cite it
  • K020394Apc Plus Adhesive3M Unitek · 20024cite it
  • K1636893M Clear Tray Aligner3M Unitek Corporation · 20174cite it
  • K073697Transbond Supreme Adhesive3M Unitek · 20083cite it
  • K062305Clarity Modified Ceramic Brackets3M Unitek · 20062cite it
  • K950514Tri-Cure Glass Ionomer Orthodontic Band Cement3M Unitek · 19951cites it

What has FDA decided for it lately?

  • K1636893M Clear Tray Aligner3M Unitek Corporation · 2017
  • K113197Apc Flash-Free Adhesive3M Unitek Corporation · 2012
  • K102803Clarity Advanced Ceramic Brackets3M Unitek Corporation · 2011
  • K100536Transbond Idb Pre-Mix Chemical Care Adhesive3M Unitek · 2010
  • K073697Transbond Supreme Adhesive3M Unitek · 2008
  • K062305Clarity Modified Ceramic Brackets3M Unitek · 2006
  • K020394Apc Plus Adhesive3M Unitek · 2002
  • K014142Unite Bonding Adhesive3M Unitek · 2002

All 6 as 3M Unitek →All 3 as 3M Unitek Corporation →