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Revotek Lc™ 001842

by Gc America Inc. 2 variants

Listed FDA GUDID listing, no authorization on record

Valid until

Not applicable

Database listing, no authorization

FDA recalls

None found

in data synced 22 Oct 2026

Documents

None

No authorization documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source GUDID, synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing NumberD0470018421 UDI-DI Date1 Aug 2016ListedStatusListed GUDID: in commercial distribution

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 22 Oct 2026.

Coverage

1 jurisdiction

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  • Withdrawn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

United States — GUDID listing Listed

Specification

GUDID

Trade Name
Revotek Lc™
Generic Name
Temporary dental crown/bridge resin
Model / Ref / Catalog
001842
Primary DI / UDI-DI
D0470018421
510(k) Number
FDA Product Code
LBH
GMDN Term
Temporary dental crown/bridge resin
Device Class
Class II
Regulation Number
872.3260
GUDID distribution status
In Commercial Distribution

Related devices

Category: Temporary dental crown/bridge resin

Cleared under the same submission (K012542)

Other devices from Gc America Inc.

See all devices from Gc America Inc. →

Properties

  • Prescription Use
  • Lot / Batch Number
  • Expiration Date

Other properties (11)

  • Sterile: No
  • Single Use: 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