Skip to content

Osstem Mixing Tip OMTA50

by OSSTEM IMPLANT Co., Ltd.

Osstem Mixing Tip OMTA50 is a Class I device made by OSSTEM IMPLANT Co., Ltd., listed in FDA GUDID since 8 Dec 2022 (UDI-DI 08800121767071), registry data as of 23 Oct 2026.

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

Source GUDID, synced 23 Oct 2026.

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number08800121767071 UDI-DI Date8 Dec 2022ListedStatusListed GUDID: in commercial distribution

Official records

Coverage

1 jurisdiction

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  • Withdrawn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

United States — GUDID listing Listed

Specification

GUDID

Trade name
Osstem Mixing Tip
Generic name
Dental impression material syringe, single-use
Model / reference
OMTA50
Primary DI / UDI-DI
08800121767071
FDA product code
EID
GMDN term
Dental impression material syringe, single-use
Device class
Class I
Regulation number
872.4565
GUDID distribution status
In Commercial Distribution

Related devices

Category: Dental impression material syringe, single-use

Other devices from OSSTEM IMPLANT Co., Ltd.

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

Properties

  • Single use
  • Premarket exempt
  • Lot / batch number
  • Serial number
  • Manufacturing date
Other properties (10, all answered No)