510(k) Report

FDA applicant

United Dental Resources Corporation

University Park, IL3 decisions2019–20210 recalls

FDA records 3 decisions for United Dental Resources Corporation (University Park, IL) from 2019 to 2021: 3 510(k) clearances. All are in product code EIH (Powder, Porcelain). Since 2016 its 510(k)s took a median of 227 days from receipt to decision, against 131 for FDA’s reviews in the same codes and years. Its devices cite 3 predicates, 0 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 United Dental Resources Corporation’s devices, and how often a recall has named them.

FDA decisions per year

2in 2021

2019: 12021: 2
2019high 2 (2021) · low 0 (2020)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2019.

FIG. 1 — United Dental Resources Corporation 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?

  • EIHPowder, Porcelain3decisions

How long do its 510(k) reviews take?

Since 2016, its 3 510(k)s took a median of 227 days from FDA’s receipt to its decision. For 510(k)s in the same product codes and years, FDA’s median was 131 days; 1 of its 3 were faster than that.

Whose devices does it build on?

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

What has FDA decided for it lately?

  • K201915GenesisZr 4Y+ (ST1100) ZirconiaUnited Dental Resources Corporation · 2021
  • K201608GenesisZr UHT700 ZirconiaUnited Dental Resources Corporation · 2021
  • K182642GenesisZr™ 4Y ZirconiaUnited Dental Resources Corporation · 2019

All 3 as United Dental Resources Corporation →