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BioHorizons PROBLYL

by Biohorizons Implant Systems Inc.

Ref PROBLYLModel BioHorizons Conical Dental Abutments

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

CE MDR

Valid until

Not listed

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

Registry data, not yet checked by deviCERTS. Source EUDAMED, GUDID, synced 23 Oct 2026. What this means

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number08472360IIAINST009QK Basic UDI-DI 00847236027100UDI-DIDate12 May 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number00847236027100 UDI-DI Date31 May 2024ListedStatusListed GUDID: in commercial distribution

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.

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  • Withdrawn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
Steel dental bur, reusable
Device Name
Conical Bone Profiling Burs
Model / Reference
PROBLYL, BioHorizons Conical Dental Abutments
Primary DI / UDI-DI
00847236027100
Basic UDI-DI
08472360IIAINST009QK
FDA Product Code
NDP
EMDN Code
Q010399 Surgical dental devices - other
GMDN Term
Steel dental bur, reusable
Device Class
Class IIa EUDAMED
Class I GUDID
Regulation Number
872.3980
EU 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
Device ClassEUDAMED
Class IIa
GUDID
Class I

Other devices from Biohorizons Implant Systems Inc.

See all devices from Biohorizons Implant Systems Inc. →

Properties

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

Other properties (18)

  • Sterile: No
  • Single Use: No
  • Implantable: 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