OssBuilder KIT HGBRK

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	Number08809917108210 UDI-DI	Date7 Aug 2023Listed	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Withdrawn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: OssBuilder KIT
Generic Name: Dental/maxillofacial surgical procedure kit, non-medicated, reusable
Model / Reference: HGBRK

Primary DI / UDI-DI: 08809917108210
FDA Product Code: NYE
GMDN Term: Dental/maxillofacial surgical procedure kit, non-medicated, reusable

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

Prescription Use
Convenience Kit
Premarket Exempt
Lot / Batch Number
Serial Number
Manufacturing Date

Other properties (8)

Sterile: No
Single Use: No
Implantable: No
Contains Latex: No
Over-the-Counter: No
Combination Product: No
HCT/P: No
Expiration Date: No