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BioHorizons MU-HAM

by Biohorizons Implant Systems Inc.

Part of a family of 46 devices: see the family page

Ref MU-HAMModel BioHorizons Dental Instruments

BioHorizons MU-HAM is a manual non-rotary dental instrument handle (EU MDR Class I; FDA Class I; FDA product code NDP, Accessories, Implant, Dental, Endosseous) made by Biohorizons Implant Systems Inc., registered in EUDAMED on 13 May 2026 (Basic UDI-DI 08472360IRINST005F2) and listed in FDA GUDID since 15 Apr 2021 (UDI-DI 00847236017880), active as of 25 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 25 Oct 2026.

Regulatory status

as of registry sync 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number08472360IRINST005F2 Basic UDI-DI 00847236017880UDI-DIDate13 May 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number00847236017880 UDI-DI Date15 Apr 2021ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI 08472360IRINST005F2 registered 13 May 2026 Active
  • FDA GUDID UDI-DI 00847236017880 listed 15 Apr 2021 Listed

Timeline

2 dated events

  1. Listed FDA GUDID 00847236017880
  2. Registered EUDAMED 08472360IRINST005F2

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  • Withdrawn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

Trade name
BioHorizons
Generic name
Manual non-rotary dental instrument handle
Device name
Additional Instruments
Model / reference
MU-HAM, BioHorizons Dental Instruments
Primary DI / UDI-DI
00847236017880
Basic UDI-DI
08472360IRINST005F2
Direct marketing DI
00847236020149
FDA product code
NDP
EMDN code
Q010399 Surgical dental devices - other
GMDN term
Manual non-rotary dental instrument handle
Device class
Class I
Regulation number
872.3980
EU registration type
Standard device
EU market of registration
Germany
GUDID distribution status
In Commercial Distribution
Sterilisation method
Moist Heat or Steam Sterilization

Related devices

Category: Manual non-rotary dental instrument handle

Similar devices in this category

Other devices filed under SURGICAL DENTAL DEVICES - OTHER.

Other devices from Biohorizons Implant Systems Inc.

See all devices from Biohorizons Implant Systems Inc. →

Properties

  • Sterilise before use
  • Reusable
  • Reprocessed single-use device
  • Prescription use
  • Premarket exempt
  • Lot / batch number
  • Manufacturing date
Other properties (18, all answered No)