510(k) Report

FDA applicant

Ultradent Products Inc. / Oratech, LLC

South Jordan, UT2 decisions2013–20132 recalls

FDA records 2 decisions for Ultradent Products Inc. / Oratech, LLC (South Jordan, UT) in 2013: 2 510(k) clearances. Most are in product codes EMA (Cement, Dental) and LBH (Varnish, Cavity). Its devices cite 2 predicates, 0 of them its own earlier devices. 2 recalls are 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 Ultradent Products Inc. / Oratech, LLC’s devices, and how often a recall has named them.

FDA decisions per year

2in 2013

2013: 2
2013high 2 (2013) · low 0 (2014)2026

2026 so far, outlined.

Recalls per year

2in 2018

2018: 2
2013high 2 (2018) · low 0 (2013)2026

Class I Class II/III not classified

FIG. 1 — Ultradent Products Inc. / Oratech, LLC by year, 2013–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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Which product codes does it file in?

  • EMACement, Dental1decision
  • LBHVarnish, Cavity1decision

Whose devices does it build on?

Its devices cite 2 predicates; 0 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 4 times; 0 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.

  • K132109EnamelastUltradent Products Inc. / Oratech, LLC · 20134cite it

What has FDA decided for it lately?

  • K132109EnamelastUltradent Products Inc. / Oratech, LLC · 20132 recalls
  • K132255UltracemUltradent Products Inc. / Oratech, LLC · 2013

All 2 as Ultradent Products Inc. / Oratech, LLC →

What has been recalled?

2 recalls linked to its devices; the latest:

  • K132109Enamelast Cool Mint/OT Varnish 5% NaF Mint Label Enamelast Unit Dose 200pk Cool Mint…Jul 12, 2018Class II
  • K1321093M Fast Release Varnish, 5% Sodium Fluoride, Mint Flavor, Rx Only, single use. 200 pack…Jul 6, 2018Class II

Other applicant names beginning “Ultradent”

FDA records each applicant name separately; these may or may not be the same firm.

Ultradent Products, Inc. 104Ultradent Product, Inc. 2