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BioHorizons OD-RC-P

by Biohorizons Implant Systems Inc.

Ref OD-RC-PModel BioHorizons Abutment Accessories

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 Number08472360IIAABUT001FM Basic UDI-DIDate11 May 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number00847236017019 UDI-DIDate15 Apr 2021ListedStatusListed 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  • Withdrawn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
Resilient dental precision attachment
Device Name
Abutment Attachments
Model / Reference
OD-RC-P, BioHorizons Abutment Accessories
Primary DI / UDI-DI
00847236017019
Basic UDI-DI
08472360IIAABUT001FM
FDA Product Code
NDP
EMDN Code
P01020180 Dental implants - accessories
GMDN Term
Resilient dental precision attachment
Device Class
Class IIb EUDAMED
Class I GUDID
Regulation Number
872.3980
Market of Registration
Germany
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 2 fields differ

FieldEUDAMEDGUDID
Device ClassEUDAMED
Class IIb
GUDID
Class I
ImplantableEUDAMED
Yes
GUDID
No

Other devices from Biohorizons Implant Systems Inc.

See all devices from Biohorizons Implant Systems Inc. →

Properties

  • Single Use
  • Implantable YesEUDAMEDNoGUDID
  • Sutures
  • Prescription Use
  • Premarket Exempt
  • Lot / Batch Number
  • Manufacturing Date

Other properties (18)

  • Sterile: No
  • Reusable: No
  • Contains Latex: No
  • Reprocessed: 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