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Fusion I Seal Intro Pack

by Prevest Denpro Limited

Ref 30002Model Sealant, Liner and Base Material

Fusion I Seal Intro Pack (30002) 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 6 Aug 2026 (Basic UDI-DI B-+D967300020_), cleared under FDA 510(k) K231263 on 5 Jan 2024 and listed in FDA GUDID since 23 Apr 2024 (UDI-DI +D967300020_), 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) K231263

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-+D967300020_ Basic UDI-DI +D967300020_UDI-DIDate6 Aug 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number+D967300020_ 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-+D967300020_ registered 6 Aug 2026 Active
  • FDA 510(k) K231263 decided 5 Jan 2024 Active
  • FDA GUDID UDI-DI +D967300020_ listed 23 Apr 2024 Listed

Timeline

3 dated events

  1. Cleared FDA 510(k) K231263
  2. Listed FDA GUDID +D967300020_
  3. Registered EUDAMED B-+D967300020_

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  • Withdrawn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 I-Seal EUDAMED
Fusion I Seal GUDID
Generic name
Dental composite resin kit
Model / Ref / Catalog
Sealant, Liner and Base Material, 30002, Intro Pack
Primary DI / UDI-DI
+D967300020_ EUDAMED
D96730002 GUDID
Basic UDI-DI
B-+D967300020_
510(k) Number
FDA product code
EBF
EMDN code
Q01010199 Dental restoration devices - other
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
Estonia
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 3 fields differ

FieldEUDAMEDGUDID
Model / referenceEUDAMED
Sealant, Liner and Base Material
30002
GUDID
Intro Pack
Primary DI / UDI-DIEUDAMED
+D967300020_
GUDID
D96730002
Device classEUDAMED
Class IIa
GUDID
Class II

The registries describe this device under different primary UDI-DIs (EUDAMED lists +D967300020_; FDA GUDID lists D96730002), 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 RESTORATION DEVICES - OTHER.

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)