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OST05

by ZimVie US Corp LLC

Part of a family of 22 devices: see the family page

Ref OST05

OST05 is a Class I device made by ZimVie US Corp LLC, registered in EUDAMED on 5 Jun 2026 (Basic UDI-DI 844868A1GS) and listed in FDA GUDID since 24 Mar 2016 (UDI-DI 00844868013433), active as of 23 Oct 2026.

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

CE MDR

Valid until

No date given

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

Source EUDAMED, GUDID, synced 23 Oct 2026.

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number844868A1GS Basic UDI-DI 00844868013433UDI-DIDate5 Jun 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number00844868013433 UDI-DI Date24 Mar 2016ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI 844868A1GS registered 5 Jun 2026 Active
  • FDA GUDID UDI-DI 00844868013433 listed 24 Mar 2016 Listed

Timeline

2 dated events

  1. Listed FDA GUDID 00844868013433
  2. Registered EUDAMED 844868A1GS

Coverage

2 jurisdictions

United States of AmericaSwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered
  • European Union CE/MDR Active
  • United States GUDID listing Listed

Specification

EUDAMED · GUDID

Generic name
Dental osteotome
Device name
Reusable Surgical Dental Instruments
Model / reference
OST05
Primary DI / UDI-DI
00844868013433
Basic UDI-DI
844868A1GS
Direct marketing DI
00844868013433
FDA product code
NDP
EMDN code
L150103 Dental osteotome blades, reusable
GMDN term
Dental osteotome
Device class
Class I
Regulation number
872.3980
EU registration type
Standard device
EU market of registration
Spain
GUDID distribution status
In Commercial Distribution
Sterilisation method
Moist Heat or Steam Sterilization

Related devices

Category: Dental osteotome

Similar devices in this category

Other devices filed under DENTAL OSTEOTOME BLADES, REUSABLE.

Other devices from ZimVie US Corp LLC

See all devices from ZimVie US Corp LLC →

Properties

  • Sterilise before use
  • Reusable
  • Contains CMR substances (carcinogenic, mutagenic or toxic to reproduction)
  • Prescription use
  • Premarket exempt
  • Lot / batch number
Other properties (19, all answered No)