510(k) Report

FDA applicant

Cosmedent, Inc.

Chicago, IL28 decisions1986–20241 recall

FDA records 28 decisions for Cosmedent, Inc. (Chicago, IL) from 1986 to 2024: 28 510(k) clearances. Most are in product codes EBF (Material, Tooth Shade, Resin) and EMA (Cement, Dental). Since 2016 its 510(k)s took a median of 74 days from receipt to decision, against 108 for FDA’s reviews in the same codes and years. Its devices cite 5 predicates, 2 of them its own earlier devices. 1 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 Cosmedent, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

1in 2024

2007: 12009: 12017: 22021: 12022: 12024: 1
2007high 2 (2017) · low 0 (2008)2026

2026 so far, outlined.

Recalls per year

1in 2017

2017: 1
2007high 1 (2017) · low 0 (2007)2026

Class I Class II/III not classified

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

Planning a device like Cosmedent, Inc.’s? A 510(k) Report ranks candidate predicates for your device by lineage, citations and recall history, with the review-time outlook.

See the 510(k) Report

Which product codes does it file in?

  • EBFMaterial, Tooth Shade, Resin12decisions
  • EMACement, Dental4decisions
  • EBDCoating, Filling Material, Resin3decisions
  • KLEAgent, Tooth Bonding, Resin2decisions
  • EBGCrown And Bridge, Temporary, Resin2decisions
  • EJRAgent, Polishing, Abrasive, Oral Cavity1decision

Also: EBC (1), ELW (1), LBH (1), MQC (1).

How long do its 510(k) reviews take?

Since 2016, its 5 510(k)s took a median of 74 days from FDA’s receipt to its decision. For 510(k)s in the same product codes and years, FDA’s median was 108 days; 4 of its 5 were faster than that.

Whose devices does it build on?

Its devices cite 5 predicates; 2 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 6 times; 2 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.

  • K070583Nano CompositeCosmedent, Inc. · 20072cite it
  • K854755Renamel Esthetic Restorative SystemCosmedent, Inc. · 19861cites it
  • K052501Multiple Resin Tooth Bonding AgentCosmedent, Inc. · 20051cites it
  • K921820Renamel Esthetic Restorative System, ModificationCosmedent, Inc. · 19921cites it
  • K924132E.Z. Temep, Temporary Filling MaterialCosmedent, Inc. · 19931cites it

What has FDA decided for it lately?

  • K240714Insure® Universal; Insure® Universal AutomixCosmedent, Inc. · 2024
  • K222435Renamel® Microhybrid ;Renamel® Flowable MicrohybridCosmedent, Inc. · 2022
  • K211259Renamel BulkfillCosmedent, Inc. · 2021
  • K172707Renamel MicrofillCosmedent, Inc. · 2017
  • K163480Renamel NANO +plusCosmedent, Inc. · 2017
  • K092730Cosmedent Brushable CompositeCosmedent, Inc. · 2009
  • K070583Nano CompositeCosmedent, Inc. · 2007
  • K060881Temporary Crown & Bridge ResinCosmedent, Inc. · 2006

All 28 as Cosmedent, Inc. →

What has been recalled?

1 recall linked to its devices; the latest:

  • K052501Cosmedent's Etching Gel, 3g, 37% Phosphoric Acid, Rx only. Packaged in 3g Luer Lock…Sep 28, 2017Class II