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Friadent® 32451441

by Dentsply Implants Manufacturing GmbH

Ref 45-1441

Friadent® 32451441 (45-1441) is a device classified as Class IIb in the EU and Class II in the US made by Dentsply Implants Manufacturing GmbH, registered in EUDAMED on 31 Oct 2026 (Basic UDI-DI B-07392532227325) and listed in FDA GUDID since 18 Nov 2020 (UDI-DI 07392532227325), active as of 7 Nov 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 7 Nov 2026.

Regulatory status

as of registry sync 7 Nov 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDD EUDAMED NumberB-07392532227325 Basic UDI-DI 07392532227325UDI-DIDate31 Oct 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number07392532227325 UDI-DI Date18 Nov 2020ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI B-07392532227325 registered 31 Oct 2026 Active
  • FDA GUDID UDI-DI 07392532227325 listed 18 Nov 2020 Listed

Timeline

2 dated events

  1. Listed FDA GUDID 07392532227325
  2. Registered EUDAMED B-07392532227325

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  • Withdrawn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
FRIADENT® Gingiva Former D3.8/GH1 EUDAMED
Friadent® GUDID
Generic name
Dental implant suprastructure, temporary, preformed, single-use
Model / Ref / Catalog
45-1441, 32451441
Primary DI / UDI-DI
07392532227325
Basic UDI-DI
B-07392532227325
FDA product code
DZE
EMDN code
P01020101 Dental implants
GMDN term
Dental implant suprastructure, temporary, preformed, single-use
Device class
Class IIb EUDAMED
Class II GUDID
Regulation number
872.3640
EU registration type
Legacy device (under a directive)
EU market of registration
Netherlands
GUDID distribution status
In Commercial Distribution
Sterilisation method
Moist Heat or Steam Sterilization

Truth per registry

2 sources · 2 fields differ

FieldEUDAMEDGUDID
Model / referenceEUDAMED
45-1441
GUDID
32451441
Device classEUDAMED
Class IIb
GUDID
Class II

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

Related devices

Category: Dental implant suprastructure, temporary, preformed, single-use

Similar devices in this category

Other devices filed under DENTAL IMPLANTS.

Other devices from Dentsply Implants Manufacturing GmbH

See all devices from Dentsply Implants Manufacturing GmbH →

Properties

  • Sterilise before use
  • Single use
  • Implantable
  • Prescription use
  • Lot / batch number
  • Expiration date
  • Manufacturing date
Other properties (18, all answered No)