Fixture Mount Screw OFMIS

by POINTIMPLANT Co., Ltd.

Listed FDA GUDID listing, no authorization on record

Valid until

Not applicable

Database listing, no authorization

FDA recalls

Not checked

No FDA submission to match recalls against

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

Region	Authorization	Number	Date	Status
United States	GUDID listing	Number08800011260644 UDI-DI	Date24 Jul 2025Listed	StatusListed GUDID: in commercial distribution

Coverage

1 jurisdiction

Active
Expiring
Withdrawn
Listed
Not covered

United States — GUDID listing Listed

Specification

GUDID

Trade name: Fixture Mount Screw
Generic name: Dental implant system
Model / reference: OFMIS

Primary DI / UDI-DI: 08800011260644
FDA product code: NDP
GMDN term: Dental implant system

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

Sterilisation method: Moist Heat or Steam Sterilization
MRI safety: MR Conditional

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Properties

Sterilise before use
Single use
Implantable
Premarket exempt
Lot / batch number
Manufacturing date

Other properties (9)

Supplied sterile: No
Contains latex: No
Prescription use: No
Over-the-counter: No
Convenience kit: No
Combination product: No
HCT/P: No
Serial number: No
Expiration date: No