Cerasmart™ 012467

by Gc America Inc.

Cerasmart™ 012467 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 5 Aug 2022 (UDI-DI 14548161320504), active as of 23 Oct 2026.

Active United States. Also listed in GUDID (US).

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 23 Oct 2026

Documents

FDA submission, from GUDID

Trust

Source GUDID, synced 23 Oct 2026.

Regulatory status

as of registry sync 23 Oct 2026

Region	Authorization	Number	Date	Status
United States	GUDID listing	Number14548161320504 UDI-DI	Date5 Aug 2022Listed	StatusListed GUDID: in commercial distribution
United States	FDA 510(k)SESE from GUDID Substantially Equivalent · Traditional	NumberK133824	Date14 Mar 2014Decided	StatusActive

Official records

AccessGUDID record UDI-DI 14548161320504
FDA 510(k) database 510(k) number K133824

Across registries

2 registries list this device

FDA 510(k) K133824 decided 14 Mar 2014 Active
FDA GUDID UDI-DI 14548161320504 listed 5 Aug 2022 Listed

Timeline

2 dated events

14 Mar 2014 Cleared FDA 510(k) K133824
5 Aug 2022 Listed FDA GUDID 14548161320504

Coverage

1 jurisdiction

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Withdrawn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: 012467

Primary DI / UDI-DI: 14548161320504
510(k) Number: K133824
FDA product code: EBF, EBG
GMDN term: Dental implant suprastructure, permanent, preformed

Device class: Class II
Regulation number: 872.3690, 872.3770
GUDID distribution status: In Commercial Distribution

Similar devices in this category

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Other devices from Gc America Inc.

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Properties

Single use
Implantable
Prescription use
Lot / batch number
Expiration date

Other properties (10, all answered No)