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Fusion Flo SE Intro Pack Bag

by Prevest Denpro Limited

Ref 20008-4Model Restorative Material

Fusion Flo SE Intro Pack Bag (20008-4) is a device classified as Class IIa in the EU and Class II in the US made by Prevest Denpro Limited, registered in EUDAMED on 11 Jul 2026 (Basic UDI-DI B-+D96720008404), cleared under FDA 510(k) K231263 on 5 Jan 2024 and listed in FDA GUDID since 23 Apr 2024 (UDI-DI +D96720008404), active as of 24 Oct 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 24 Oct 2026

Documents

None linked in EUDAMED

A group certificate may exist

510(k) K231263

FDA submission, from GUDID

Trust

Unverified

Source EUDAMED, GUDID, synced 24 Oct 2026.

Regulatory status

as of registry sync 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDD EUDAMED NumberB-+D96720008404 Basic UDI-DI +D96720008404UDI-DIDate11 Jul 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number+D96720008404 UDI-DI Date23 Apr 2024ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE GUDID from GUDID Substantially Equivalent · Traditional NumberK231263 Date5 Jan 2024DecidedStatusActive

Official records

Across registries

3 registries list this device

  • EUDAMED Basic UDI-DI B-+D96720008404 registered 11 Jul 2026 Active
  • FDA 510(k) K231263 decided 5 Jan 2024 Active
  • FDA GUDID UDI-DI +D96720008404 listed 23 Apr 2024 Listed

Timeline

3 dated events

  1. Cleared FDA 510(k) K231263
  2. Listed FDA GUDID +D96720008404
  3. Registered EUDAMED B-+D96720008404

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  • Withdrawn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
Fusion Flo SE
Generic name
Dental composite resin kit
Model / Ref / Catalog
Restorative Material, 20008-4, Intro Pack Bag
Primary DI / UDI-DI
+D96720008404 EUDAMED
D967200084 GUDID
Basic UDI-DI
B-+D96720008404
510(k) Number
FDA product code
EBF
EMDN code
Q01010103 Dental restorative composites
GMDN term
Dental composite resin kit
Device class
Class IIa EUDAMED
Class II GUDID
Regulation number
872.3690
EU registration type
Legacy device (under a directive)
EU market of registration
Hungary
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 3 fields differ

FieldEUDAMEDGUDID
Model / referenceEUDAMED
Restorative Material
20008-4
GUDID
Intro Pack Bag
Primary DI / UDI-DIEUDAMED
+D96720008404
GUDID
D967200084
Device classEUDAMED
Class IIa
GUDID
Class II

The registries describe this device under different primary UDI-DIs (EUDAMED lists +D96720008404; FDA GUDID lists D967200084), so their flags are not compared. 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 composite resin kit

Cleared under the same submission (K231263)

and 8 more cleared under K231263

Similar devices in this category

Other devices filed under DENTAL RESTORATIVE COMPOSITES.

Other devices from Prevest Denpro Limited

See all devices from Prevest Denpro Limited →

Properties

  • Prescription use
  • Lot / batch number
  • Expiration date
  • Manufacturing date
Other properties (19, all answered No)