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Fibrafill® FLOW F-005

by ADM, a.s.

Ref F-005

Fibrafill® FLOW F-005 is a device classified as Class IIa in the EU and Class II in the US made by ADM, a.s., registered in EUDAMED on 29 Aug 2025 (Basic UDI-DI 85956527FLOW3Q), cleared under FDA 510(k) K952353 on 10 Aug 1995 and listed in FDA GUDID since 10 Dec 2021 (UDI-DI 08595652700689), active as of 23 Oct 2026.

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

CE MDR 510(k)

Valid until

No date given

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

FDA recalls

None found

in data synced 23 Oct 2026

Documents

None linked in EUDAMED

A group certificate may exist

510(k) K952353

FDA submission, from GUDID

Trust

Unverified

Source EUDAMED, GUDID, synced 23 Oct 2026.

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number85956527FLOW3Q Basic UDI-DI 08595652700689UDI-DIDate29 Aug 2025RegisteredStatusActive
United StatesGUDID listing GUDID Number08595652700689 UDI-DI Date10 Dec 2021ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE GUDID from GUDID Substantially Equivalent · Traditional NumberK952353 Date10 Aug 1995DecidedStatusActive

Official records

Across registries

3 registries list this device

  • EUDAMED Basic UDI-DI 85956527FLOW3Q registered 29 Aug 2025 Active
  • FDA 510(k) K952353 decided 10 Aug 1995 Active
  • FDA GUDID UDI-DI 08595652700689 listed 10 Dec 2021 Listed

Timeline

3 dated events

  1. Cleared FDA 510(k) K952353
  2. Listed FDA GUDID 08595652700689
  3. Registered EUDAMED 85956527FLOW3Q

Coverage

2 jurisdictions

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  • Withdrawn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

Specification

EUDAMED · GUDID

Trade name
Fibrafill® FLOW
Generic name
Dental reinforcing fibre
Model / Ref / Catalog
F-005
Primary DI / UDI-DI
08595652700689
Basic UDI-DI
85956527FLOW3Q
510(k) Number
FDA product code
EBF
EMDN code
Q01010103 Dental restorative composites
GMDN term
Dental reinforcing fibre
Device class
Class IIa EUDAMED
Class II GUDID
Regulation number
872.3690
EU registration type
Standard device
EU market of registration
Czechia
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 2 fields differ

FieldEUDAMEDGUDID
Device classEUDAMED
Class IIa
GUDID
Class II
ImplantableEUDAMED
Yes
GUDID
No

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 (K952353)

and 2 more cleared under K952353

Similar devices in this category

Other devices filed under DENTAL RESTORATIVE COMPOSITES.

Other devices from ADM, a.s.

See all devices from ADM, a.s. →

Properties

  • Single use
  • Implantable YesEUDAMEDNoGUDID
  • Lot / batch number
  • Expiration date
Other properties (21, all answered No)