510(k) Report

FDA applicant

Dr. Collins, Inc.

Irvine, CA2 decisions2019–20200 recalls

FDA records 2 decisions for Dr. Collins, Inc. (Irvine, CA) from 2019 to 2020: 2 510(k) clearances. All are in product code LBH (Varnish, Cavity). Its devices cite 1 predicate, 1 of them its own earlier devices. No 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 Dr. Collins, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

1in 2020

2019: 12020: 1
2019high 1 (2019) · low 0 (2021)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2019.

FIG. 1 — Dr. Collins, Inc. by year, 2019–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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Which product codes does it file in?

  • LBHVarnish, Cavity2decisions

Who builds on its devices?

Later devices cite its devices 2 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.

  • K181965Restore ToothpasteDr. Collins, Inc. · 20191cites it
  • K200077BioMin Restore PlusDr. Collins, Inc. · 20201cites it

What has FDA decided for it lately?

  • K200077BioMin Restore PlusDr. Collins, Inc. · 2020
  • K181965Restore ToothpasteDr. Collins, Inc. · 2019

All 2 as Dr. Collins, Inc. →