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Cerasmart® 011959

by Gc America Inc.

Cerasmart® 011959 is a Class II device made by Gc America Inc., cleared under FDA 510(k) K133824 on 14 Mar 2014 and listed in FDA GUDID since 16 Oct 2017 (UDI-DI D0470119591), active (FDA 510(k)), not in commercial distribution (GUDID) as of 22 Oct 2026.

Active United States. Also listed in GUDID (US), not in commercial distribution.

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 22 Oct 2026

Documents

510(k) K133824

FDA submission, from GUDID

Trust

Unverified

Source GUDID, synced 22 Oct 2026.

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing NumberD0470119591 UDI-DI Date16 Oct 2017ListedStatusListed GUDID: not in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK133824 Date14 Mar 2014DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K133824 decided 14 Mar 2014 Active
  • FDA GUDID UDI-DI D0470119591 listed 16 Oct 2017 Listed

Timeline

2 dated events

  1. Cleared FDA 510(k) K133824
  2. Listed FDA GUDID D0470119591

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

GUDID

Trade name
Cerasmart®
Generic name
Dental implant suprastructure, permanent, preformed
Model / Ref / Catalog
011959
Primary DI / UDI-DI
D0470119591
510(k) Number
FDA product code
EBG, EBF
GMDN term
Dental implant suprastructure, permanent, preformed
Device class
Class II
Regulation number
872.3770, 872.3690
GUDID distribution status
Not in Commercial Distribution

Related devices

Cleared under the same submission (K133824)

and 8 more cleared under K133824

Similar devices

Other devices filed under FDA product code EBG (CROWN AND BRIDGE, TEMPORARY, RESIN).

Other devices from Gc America Inc.

See all devices from Gc America Inc. →

Properties

  • Single use
  • Implantable
  • Prescription use
  • Lot / batch number
  • Expiration date
Other properties (10, all answered No)