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Infibra IF4

by Bioloren SRL

Ref IF4

Infibra IF4 is a device classified as Class IIa in the EU and Class II in the US made by Bioloren SRL, registered in EUDAMED on 4 Nov 2026 (Basic UDI-DI B-08056099230042), cleared under FDA 510(k) K061735 on 8 Sep 2006 and listed in FDA GUDID since 23 Sep 2016 (UDI-DI 08056099230042), active as of 7 Nov 2026.

Active European Union and United States. Also listed in GUDID (US).

CE MDD 510(k)

Valid until

No date given

CE: no date in EUDAMED. FDA: not time-limited

FDA recalls

None found

in data synced 7 Nov 2026

Documents

None linked in EUDAMED

A group certificate may exist

510(k) K061735

FDA submission, from GUDID

Trust

Unverified

Source EUDAMED, GUDID, synced 7 Nov 2026.

Regulatory status

as of registry sync 7 Nov 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDD EUDAMED NumberB-08056099230042 Basic UDI-DI 08056099230042UDI-DIDate4 Nov 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number08056099230042 UDI-DI Date23 Sep 2016ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE GUDID from GUDID Substantially Equivalent · Traditional NumberK061735 Date8 Sep 2006DecidedStatusActive

Official records

Across registries

3 registries list this device

  • EUDAMED Basic UDI-DI B-08056099230042 registered 4 Nov 2026 Active
  • FDA 510(k) K061735 decided 8 Sep 2006 Active
  • FDA GUDID UDI-DI 08056099230042 listed 23 Sep 2016 Listed

Timeline

3 dated events

  1. Cleared FDA 510(k) K061735
  2. Listed FDA GUDID 08056099230042
  3. Registered EUDAMED B-08056099230042

Coverage

2 jurisdictions

United States of AmericaSwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered
  • European Union CE/MDD Active
  • United States FDA 510(k) Active

Specification

EUDAMED · GUDID

Trade name
Infibra
Generic name
Dental reinforcing fibre
Model / reference
IF4
Primary DI / UDI-DI
08056099230042
Basic UDI-DI
B-08056099230042
510(k) Number
FDA product code
EBI
EMDN code
Q01010199 Dental restoration devices - other
GMDN term
Dental reinforcing fibre
Device class
Class IIa EUDAMED
Class II GUDID
Regulation number
872.3760
EU registration type
Legacy device (under a directive)
EU market of registration
Italy
GUDID distribution status
In Commercial Distribution
Size
Height — 4 Millimeter

Truth per registry

2 sources · 1 field differs

FieldEUDAMEDGUDID
Device classEUDAMED
Class IIa
GUDID
Class II

Device class is stated on each registry's own scale: Class IIa 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 reinforcing fibre

Cleared under the same submission (K061735)

and 2 more cleared under K061735

Similar devices in this category

Other devices filed under DENTAL RESTORATION DEVICES - OTHER.

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Properties

  • Lot / batch number
Other properties (22, all answered No)