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Osteotome Mallet HOSTM

by OSSTEM IMPLANT 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

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number08800209371619 UDI-DI Date7 Aug 2023ListedStatusListed GUDID: in commercial distribution

Coverage

1 jurisdiction

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  • Withdrawn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

United States — GUDID listing Listed

Specification

GUDID

Trade Name
Osteotome Mallet
Generic Name
Dental osteotome
Model / Reference
HOSTM
Primary DI / UDI-DI
08800209371619
FDA Product Code
EIF
GMDN Term
Dental osteotome
Device Class
Class I
Regulation Number
872.4565
GUDID distribution status
In Commercial Distribution
Sterilization Method
Moist Heat or Steam Sterilization

Related devices

Category: Dental osteotome

Other devices from OSSTEM IMPLANT Co., Ltd.

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

Properties

  • Prescription Use
  • Premarket Exempt
  • Lot / Batch Number
  • Serial Number
  • Manufacturing Date

Other properties (9)

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