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BioHorizons TRE34

by Biohorizons Implant Systems Inc.

Ref TRE34Model BioHorizons Dental Instruments

BioHorizons TRE34 is a Class I device made by Biohorizons Implant Systems Inc., registered in EUDAMED on 13 May 2026 (Basic UDI-DI 08472360IRINST001ES) and listed in FDA GUDID since 15 Dec 2017 (UDI-DI 00847236012342), 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 Number08472360IRINST001ES Basic UDI-DI 00847236012342UDI-DIDate13 May 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number00847236012342 UDI-DI Date15 Dec 2017ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI 08472360IRINST001ES registered 13 May 2026 Active
  • FDA GUDID UDI-DI 00847236012342 listed 15 Dec 2017 Listed

Timeline

2 dated events

  1. Listed FDA GUDID 00847236012342
  2. Registered EUDAMED 08472360IRINST001ES

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  • Withdrawn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
Dental osteotome
Device name
Tapered Ridge Expanders
Model / reference
TRE34, BioHorizons Dental Instruments
Primary DI / UDI-DI
00847236012342
Basic UDI-DI
08472360IRINST001ES
FDA product code
NDP
EMDN code
Q010399 Surgical dental devices - other
GMDN term
Dental osteotome
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: Dental osteotome

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)