COSMEDENT, INC.
2 recall(s) on record — most severe on record: Class II.
Recalls by year
- Recalls (2)
Registered facilities (1)
- COSMEDENT, INC. FEI 1450653 · IL
Recalls & enforcement
- Class IIOngoing2023-07-20Reports were received the elastomer cup material is crumbling.
- Class IITerminated2017-09-28Product packaged in a syringe that is not a lure lock syringe and the tip cold come off when expressing the material.
Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. We restate the public record only — measured facts, never risk verdicts.
Cite this record
RegWarden. “COSMEDENT, INC. — FDA compliance profile.” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/company/oo-1450653-cosmedent-inc/
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