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Renamel® Microhybrid 6062LI

by Cosmedent, Inc.

Listed FDA GUDID listing, no authorization on record

Valid until

Not applicable

Database listing, no authorization

FDA recalls

None found

in data synced 23 Oct 2026

Documents

None

No authorization documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source GUDID, synced 23 Oct 2026. What this means

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing NumberD7796062LI1 UDI-DI Date22 Sep 2016ListedStatusListed GUDID: in commercial distribution

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 23 Oct 2026.

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — GUDID listing Listed

Specification

GUDID

Trade Name
Renamel® Microhybrid
Generic Name
Dental composite resin
Model / Ref / Catalog
6062LI
Primary DI / UDI-DI
D7796062LI1
510(k) Number
FDA Product Code
EBF
GMDN Term
Dental composite resin
Device Class
Class II
Regulation Number
872.3690
GUDID distribution status
In Commercial Distribution

From the manufacturer

Manufacturer's product page: Renamel Microhybrid Composite

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Category: Dental composite resin

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Properties

  • Single Use
  • Prescription Use
  • Lot / Batch Number
  • Expiration Date

Other properties (10)

  • Sterile: No
  • Implantable: No
  • Contains Latex: No
  • Over-the-Counter: No
  • Convenience Kit: No
  • Combination Product: No
  • HCT/P: No
  • Premarket Exempt: No
  • Serial Number: No
  • Manufacturing Date: No