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Cytrans Granules 10007518

by Gc America Inc. 2 variants

Cytrans Granules 10007518 (014362) 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 1 Apr 2022 (UDI-DI 04548161312151), active (FDA 510(k)), not in commercial distribution (GUDID) as of 23 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 23 Oct 2026

Documents

510(k) K192597

FDA submission, from GUDID

Trust

Unverified

Source GUDID, synced 23 Oct 2026.

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number04548161312151 UDI-DI Date1 Apr 2022ListedStatusListed GUDID: not in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Abbreviated NumberK192597 Date17 Aug 2020DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K192597 decided 17 Aug 2020 Active
  • FDA GUDID UDI-DI 04548161312151 listed 1 Apr 2022 Listed

Timeline

2 dated events

  1. Cleared FDA 510(k) K192597
  2. Listed FDA GUDID 04548161312151

Coverage

1 jurisdiction

United States of America
  • 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  • Withdrawn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
10007518, 014362
Primary DI / UDI-DI
04548161312151
510(k) Number
FDA product code
LYC
GMDN term
Dental bone void filling material, synthetic
Device class
Class II
Regulation number
872.3930
GUDID distribution status
Not in Commercial Distribution

Related devices

Cleared under the same submission (K192597)

and 8 more cleared under K192597

Similar devices

Other devices filed under FDA product code LYC (Bone grafting material, synthetic).

Other devices from Gc America Inc.

See all devices from Gc America Inc. →

Properties

  • Supplied sterile
  • Single use
  • Implantable
  • Prescription use
  • Lot / batch number
  • Expiration date
Other properties (9, all answered No)