510(k) Report

FDA applicant

Ultradent Product, Inc.

South Jordan, UT2 decisions2020–20232 recalls

FDA records 2 decisions for Ultradent Product, Inc. (South Jordan, UT) from 2020 to 2023: 2 510(k) clearances. Most are in product codes EBF (Material, Tooth Shade, Resin) and EBC (Sealant, Pit And Fissure, And Conditioner). Its devices cite 3 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 Product, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

1in 2023

2020: 12023: 1
2020high 1 (2020) · low 0 (2021)2026

2026 so far, outlined.

Recalls per year

2in 2024

2024: 2
2020high 2 (2024) · low 0 (2020)2026

Class I Class II/III not classified

FIG. 1 — Ultradent Product, Inc. by year, 2020–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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Which product codes does it file in?

  • EBFMaterial, Tooth Shade, Resin1decision
  • EBCSealant, Pit And Fissure, And Conditioner1decision

Whose devices does it build on?

Its devices cite 3 predicates; 0 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 1 time; 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.

  • K201795TranscendUltradent Product, Inc. · 20201cites it

What has FDA decided for it lately?

  • K232498UltraSeal XT plus - Bioprotection by Nobio, UltraSeal XT hydro - Bioprotection by NobioUltradent Product, Inc. · 2023
  • K201795TranscendUltradent Product, Inc. · 20202 recalls

All 2 as Ultradent Product, Inc. →

What has been recalled?

2 recalls linked to its devices; the latest:

  • K201795Brand Name: Transcend Product Name: Transcend Singles Universal Body (UB) Refill 10pk…Aug 2, 2024Class II
  • K201795Brand Name: Transcend Product Name: Transcend Econo Kit (UB) - Singles Model/Catalog…Aug 2, 2024Class 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 Products Inc. / Oratech, LLC 2