Cytrans Granules 014360

by Gc America Inc.

Cytrans Granules 014360 is a Class II device made by Gc America Inc., cleared under FDA 510(k) K192597 on 17 Aug 2020 and listed in FDA GUDID since 12 Aug 2022 (UDI-DI 14548161312134), 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	Number14548161312134 UDI-DI	Date12 Aug 2022Listed	StatusListed GUDID: in commercial distribution
United States	FDA 510(k)SESE from GUDID Substantially Equivalent · Abbreviated	NumberK192597	Date17 Aug 2020Decided	StatusActive

Official records

AccessGUDID record UDI-DI 14548161312134
FDA 510(k) database 510(k) number K192597

Across registries

2 registries list this device

FDA 510(k) K192597 decided 17 Aug 2020 Active
FDA GUDID UDI-DI 14548161312134 listed 12 Aug 2022 Listed

Timeline

2 dated events

17 Aug 2020 Cleared FDA 510(k) K192597
12 Aug 2022 Listed FDA GUDID 14548161312134

Coverage

1 jurisdiction

Active
Expiring
Withdrawn
Listed
Not covered

United States — FDA 510(k) Active

Specification

GUDID

Trade name: Cytrans Granules
Generic name: Dental bone void filling material, synthetic
Model / Ref / Catalog: 014360

Primary DI / UDI-DI: 14548161312134
510(k) Number: K192597
FDA product code: LYC
GMDN term: Dental bone void filling material, synthetic

Device class: Class II
Regulation number: 872.3930
GUDID distribution status: In Commercial Distribution

Similar devices in this category

Other devices filed under Dental bone matrix implant, synthetic.

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Properties

Supplied sterile
Single use
Implantable
Prescription use
Lot / batch number
Expiration date

Other properties (9, all answered No)