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Ts Fixture System GSCS40S-G

by OSSTEM IMPLANT Co., Ltd.

Listed FDA GUDID listing, no authorization on record

Valid until

Not applicable

Database listing, no authorization

FDA recalls

None found

in data synced 23 Oct 2026

Documents

None

No authorization documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source GUDID, synced 23 Oct 2026. What this means

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number08800000921471 UDI-DI Date14 Oct 2015ListedStatusListed GUDID: in commercial distribution

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 23 Oct 2026.

Coverage

1 jurisdiction

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  • Withdrawn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

United States — GUDID listing Listed

Specification

GUDID

Trade Name
Ts Fixture System
Generic Name
Screw endosteal dental implant, two-piece
Model / Reference
GSCS40S-G
Primary DI / UDI-DI
08800000921471
510(k) Number
FDA Product Code
NHA
GMDN Term
Screw endosteal dental implant, two-piece
Device Class
Class II
Regulation Number
872.3630
GUDID distribution status
In Commercial Distribution

Related devices

Category: Screw endosteal dental implant, two-piece

Cleared under the same submission (K121995)

Show all (12)

Other devices from OSSTEM IMPLANT Co., Ltd.

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Properties

  • Sterile
  • Single Use
  • Implantable
  • Prescription Use
  • Lot / Batch Number
  • Serial Number
  • Expiration Date
  • Manufacturing Date

Other properties (6)

  • Contains Latex: No
  • Over-the-Counter: No
  • Convenience Kit: No
  • Combination Product: No
  • HCT/P: No
  • Premarket Exempt: No