510(k) Report

FDA applicant

Roydent Dental Products, Inc.

Rochester Hills, MI3 decisions1996–19990 recalls

FDA records 3 decisions for Roydent Dental Products, Inc. (Rochester Hills, MI) from 1996 to 1999: 3 510(k) clearances. Most are in product codes EBI (Resin, Denture, Relining, Repairing, Rebasing) and ELW (Material, Impression). Its devices cite 4 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 Roydent Dental Products, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Roydent Dental Products, Inc. since 2007.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — Roydent Dental Products, Inc. by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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Which product codes does it file in?

  • EBIResin, Denture, Relining, Repairing, Rebasing1decision
  • ELWMaterial, Impression1decision
  • EBDCoating, Filling Material, Resin1decision

Whose devices does it build on?

Its devices cite 4 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.

  • K954281Panasil Impression MaterialRoydent Dental Products, Inc. · 19964cite it

What has FDA decided for it lately?

  • K984037Core-IdeRoydent Dental Products, Inc. · 1999
  • K983357Mucopren Soft Relining SystemRoydent Dental Products, Inc. · 1998
  • K954281Panasil Impression MaterialRoydent Dental Products, Inc. · 1996

All 3 as Roydent Dental Products, Inc. →