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BioHorizons TRYPBMU17

by Biohorizons Implant Systems Inc. EUDAMEDGUDID

Active European Union

Ref TRYPBMU17Model BioHorizons Dental Instruments

Regulatory status

as of 29 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number08472360IRINST003EW Basic UDI-DIDate13 May 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number00847236013363 UDI-DIDate24 Oct 2018ListedStatusListed GUDID: in commercial distribution

Coverage

2 jurisdictions

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  • Withdrawn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

Certificates

0 certificates · EUDAMED

EUDAMED lists no certificate for this device's Basic UDI-DI.

A certificate issued for a device group may exist without being linked here.

Recalls

0 recalls · FDA

No FDA recalls on record, checked 23 Oct 2026.

Specification

EUDAMED · GUDID

Trade Name
BioHorizons
Generic Name
Dental implant suprastructure, temporary, preformed, single-use
Device Name
Try-Ins
Model / Reference
TRYPBMU17, BioHorizons Dental Instruments
Primary DI / UDI-DI
00847236013363
Basic UDI-DI
08472360IRINST003EW
Direct Marketing DI
00847236020620
FDA Product Code
NDP
EMDN Code
Q010399 Surgical dental devices - other
GMDN Term
Dental implant suprastructure, temporary, preformed, single-use
Device Class
Class I
Regulation Number
872.3980
Market of Registration
Germany
GUDID distribution status
In Commercial Distribution
Sterilization Method
Moist Heat or Steam Sterilization

Truth per registry

2 sources · 1 field differs

FieldEUDAMEDGUDID
ImplantableEUDAMED
No
GUDID
Yes

Other devices from Biohorizons Implant Systems Inc.

See all devices from Biohorizons Implant Systems Inc. →

Properties

  • Implantable NoEUDAMEDYesGUDID
  • Reusable
  • Reprocessed
  • Prescription Use
  • Premarket Exempt
  • Lot / Batch Number
  • Manufacturing Date

Other properties (17)

  • Sterile: No
  • Single Use: No
  • Contains Latex: No
  • CMR Substance: No
  • Human-derived: No
  • Human Tissues: No
  • Animal Tissues: No
  • Endocrine Disruptor: No
  • Administering Medicine: No
  • Measuring Function: No
  • Incorporates Medicinal Product: No
  • Over-the-Counter: No
  • Convenience Kit: No
  • Combination Product: No
  • HCT/P: No
  • Serial Number: No
  • Expiration Date: No