US Fixture Pick-up Impression Coping TICFW600

by OSSTEM IMPLANT Co., Ltd.

Active European Union. Also listed in GUDID (US).

CE MDR

Valid until

Not listed

EUDAMED holds no validity date

FDA recalls

Not checked

No FDA submission to match recalls against

Documents

None linked in EUDAMED

A group certificate may exist

Trust

Unverified

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

Regulatory status

as of registry sync 23 Oct 2026

Region	Authorization	Number	Date	Status
United States	GUDID listing GUDID	Number08800040612438 UDI-DI	Date8 Dec 2022Listed	StatusListed GUDID: in commercial distribution
European Union	CE/MDR EUDAMED	Number—	Date—	StatusActive

Coverage

2 jurisdictions

Active
Expiring
Withdrawn
Listed
Not covered

European Union CE/MDR Active
United States GUDID listing Listed

Specification

EUDAMED · GUDID

Trade Name: US Fixture Pick-up Impression Coping
Generic Name: Dental implant suprastructure, temporary, preformed, single-use
Model / Reference: TICFW600

Primary DI / UDI-DI: 08800040612438
FDA Product Code: NDP
GMDN Term: Dental implant suprastructure, temporary, preformed, single-use

Device Class: Class I
Regulation Number: 872.3980
GUDID distribution status: In Commercial Distribution

Sterilization Method: Moist Heat or Steam Sterilization

Other devices from OSSTEM IMPLANT Co., Ltd.

See all devices from OSSTEM IMPLANT Co., Ltd. →

Properties

Single Use
Implantable
Prescription Use
Premarket Exempt
Lot / Batch Number
Serial Number
Manufacturing Date

Other properties (7)

Sterile: No
Contains Latex: No
Over-the-Counter: No
Convenience Kit: No
Combination Product: No
HCT/P: No
Expiration Date: No