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Fusion Bond DC Intro Pack

by Prevest Denpro Limited

Ref 10005Model Adhesives

Fusion Bond DC Intro Pack (10005) is a dental acrylic resin kit (EU MDD Class IIa; FDA Class II; FDA product code KLE, Agent, Tooth Bonding, Resin) made by Prevest Denpro Limited, registered in EUDAMED on 19 Sep 2026 (Basic UDI-DI B-+D967100050), cleared under FDA 510(k) K231696 on 11 Aug 2023 and listed in FDA GUDID since 23 Apr 2024 (UDI-DI +D967100050), active as of 25 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 25 Oct 2026

Documents

None linked in EUDAMED

A group certificate may exist

510(k) K231696

FDA submission, from GUDID

Trust

Unverified

Source EUDAMED, GUDID, synced 25 Oct 2026.

Regulatory status

as of registry sync 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDD EUDAMED NumberB-+D967100050 Basic UDI-DI +D967100050UDI-DIDate19 Sep 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number+D967100050 UDI-DI Date23 Apr 2024ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE GUDID from GUDID Substantially Equivalent · Traditional NumberK231696 Date11 Aug 2023DecidedStatusActive

Official records

Across registries

3 registries list this device

  • EUDAMED Basic UDI-DI B-+D967100050 registered 19 Sep 2026 Active
  • FDA 510(k) K231696 decided 11 Aug 2023 Active
  • FDA GUDID UDI-DI +D967100050 listed 23 Apr 2024 Listed

Timeline

3 dated events

  1. Cleared FDA 510(k) K231696
  2. Listed FDA GUDID +D967100050
  3. Registered EUDAMED B-+D967100050

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  • Withdrawn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 Bond DC
Generic name
Dental acrylic resin kit
Model / Ref / Catalog
Adhesives, 10005, Intro Pack
Primary DI / UDI-DI
+D967100050 EUDAMED
D96710005 GUDID
Basic UDI-DI
B-+D967100050
510(k) Number
FDA product code
KLE
EMDN code
Q01010104 Dental bonding agents
GMDN term
Dental acrylic resin kit
Device class
Class IIa EUDAMED
Class II GUDID
Regulation number
872.3200
EU registration type
Legacy device (under a directive)
EU market of registration
Ireland
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 3 fields differ

FieldEUDAMEDGUDID
Model / referenceEUDAMED
Adhesives
10005
GUDID
Intro Pack
Primary DI / UDI-DIEUDAMED
+D967100050
GUDID
D96710005
Device classEUDAMED
Class IIa
GUDID
Class II

The registries describe this device under different primary UDI-DIs (EUDAMED lists +D967100050; FDA GUDID lists D96710005), 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 acrylic resin kit

Cleared under the same submission (K231696)

and 5 more cleared under K231696

Similar devices in this category

Other devices filed under DENTAL BONDING AGENTS.

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)