Skip to content

Pro-fix™ Precision Fixation System PFDH

by Osteogenics Biomedical, Inc.

Ref PFDHModel Screw Fixation System - Instrument

Pro-fix™ Precision Fixation System PFDH is a device classified as Class IIb in the EU and Class I in the US made by Osteogenics Biomedical, Inc., registered in EUDAMED on 20 Aug 2026 (Basic UDI-DI B-D765PFDH0) and listed in FDA GUDID since 17 Jan 2023 (UDI-DI D765PFDH0), active as of 23 Oct 2026.

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

CE MDD

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/MDD EUDAMED NumberB-D765PFDH0 Basic UDI-DI D765PFDH0UDI-DIDate20 Aug 2026RegisteredStatusActive
United StatesGUDID listing GUDID NumberD765PFDH0 UDI-DI Date17 Jan 2023ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI B-D765PFDH0 registered 20 Aug 2026 Active
  • FDA GUDID UDI-DI D765PFDH0 listed 17 Jan 2023 Listed

Timeline

2 dated events

  1. Listed FDA GUDID D765PFDH0
  2. Registered EUDAMED B-D765PFDH0

Coverage

2 jurisdictions

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  • Withdrawn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

Specification

EUDAMED · GUDID

Trade name
Pro-Fix Precision Fixation System EUDAMED
Pro-fix™ Precision Fixation System GUDID
Generic name
Surgical instrument handle, non-torque-limiting
Device name
Pro-Fix Driver Handle
Model / reference
PFDH, Screw Fixation System - Instrument
Primary DI / UDI-DI
D765PFDH0
Basic UDI-DI
B-D765PFDH0
FDA product code
EJB
EMDN code
Q010399 Surgical dental devices - other
GMDN term
Surgical instrument handle, non-torque-limiting
Device class
Class IIb EUDAMED
Class I GUDID
Regulation number
872.4565
EU registration type
Legacy device (under a directive)
EU market of registration
Germany
GUDID distribution status
In Commercial Distribution
Sterilisation method
Moist Heat or Steam Sterilization

Truth per registry

2 sources · 1 field differs

FieldEUDAMEDGUDID
Device classEUDAMED
Class IIb
GUDID
Class I

Device class is stated on each registry's own scale: Class IIb in the EU (EUDAMED), Class I in the US (FDA GUDID). EU and US classes are different schemes, so this is not a disagreement.

Related devices

Category: Surgical instrument handle, non-torque-limiting

Similar devices in this category

Other devices filed under SURGICAL DENTAL DEVICES - OTHER.

Other devices from Osteogenics Biomedical, Inc.

See all devices from Osteogenics Biomedical, Inc. →

Properties

  • Sterilise before use
  • Reusable
  • Prescription use
  • Premarket exempt
  • Lot / batch number
  • Manufacturing date
Other properties (19, all answered No)