Medical device makerLabelled by claude-haiku-5.5 from the firm's FDA names. It is not an FDA field. in United StatesLabelled by claude-haiku-5.5 from the firm's FDA names. It is not an FDA field.. FDA records under 2 spellings of its name, each linked to the record.
As of Nov 14, 2026, FDA's public records list Cosmedent with 28 510(k) clearances and 2 device recalls. The most recent is a 510(k) clearance dated Jul 24, 2024: Insure® Universal; Insure® Universal Automix.
Drug approvals, 510(k) clearances, recalls and letters, 2017 to 2026 to date
A hatched bar is a year that is not over, so its count covers only part of the year.
| Jul 24, 2024 | Insure® Universal; Insure® Universal AutomixK240714 · EMA | 510(k) clearances |
| Jul 20, 2023 | Cosmedent FlexiCup Composite Finishing & Polishing System, Six Pack, Autoclavable Aluminum Oxide Polishing Instrument, Medium (Blue), REF #4Class II · Reports were received the elastomer cup material is crumbling. | Device recalls |
| Oct 11, 2022 | Renamel® Microhybrid ;Renamel® Flowable MicrohybridK222435 · EBF | 510(k) clearances |
| Jun 24, 2021 | Renamel BulkfillK211259 · EBF | 510(k) clearances |
| Dec 5, 2017 | Renamel MicrofillK172707 · EBF | 510(k) clearances |
| Sep 28, 2017 | Cosmedent's Etching Gel, 3g, 37% Phosphoric Acid, Rx only. Packaged in 3g Luer Lock syringes. Used for etching enamel and dentin.Class II · Product packaged in a syringe that is not a lure lock syringe and the tip cold come off when expressing the material. | Device recalls |
| Feb 24, 2017 | Renamel NANO +plusK163480 · EBF | 510(k) clearances |
| Nov 20, 2009 | COSMEDENT BRUSHABLE COMPOSITEK092730 · EBF | 510(k) clearances |
| Apr 16, 2007 | NANO COMPOSITEK070583 · EBF | 510(k) clearances |
| May 16, 2006 | TEMPORARY CROWN & BRIDGE RESINK060881 · EBG | 510(k) clearances |
Spellings are joined only when they reduce to the same name, or a reviewed source names the same company. Sharing an FDA establishment number (FEI) is not enough: contract sites make products for many firms. Facts marked AI were labelled by a language model from the firm's FDA names; everything else comes from FDA or Wikidata. How this page is built
