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ParaBond 7494

by Coltène/Whaledent AG

Ref 7494Model PARABOND

ParaBond 7494 is a device classified as Class IIa in the EU and Class II in the US made by Coltène/Whaledent AG, registered in EUDAMED on 26 Oct 2026 (Basic UDI-DI B-J00674940), cleared under FDA 510(k) K053040 on 9 Nov 2005 and listed in FDA GUDID since 15 Aug 2016 (UDI-DI J00674940), 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) K053040

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-J00674940 Basic UDI-DI J00674940UDI-DIDate26 Oct 2026RegisteredStatusActive
United StatesGUDID listing GUDID NumberJ00674940 UDI-DI Date15 Aug 2016ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE GUDID from GUDID Substantially Equivalent · Traditional NumberK053040 Date9 Nov 2005DecidedStatusActive

Official records

Across registries

3 registries list this device

  • EUDAMED Basic UDI-DI B-J00674940 registered 26 Oct 2026 Active
  • FDA 510(k) K053040 decided 9 Nov 2005 Active
  • FDA GUDID UDI-DI J00674940 listed 15 Aug 2016 Listed

Timeline

3 dated events

  1. Cleared FDA 510(k) K053040
  2. Listed FDA GUDID J00674940
  3. Registered EUDAMED B-J00674940

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  • Withdrawn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
Parabond Non Rinse Cond. Ref. EUDAMED
ParaBond GUDID
Generic name
Dentine bonding agent/set
Model / Ref / Catalog
7494, PARABOND
Primary DI / UDI-DI
J00674940
Basic UDI-DI
B-J00674940
510(k) Number
FDA product code
EMA
EMDN code
Q01010104 Dental bonding agents
GMDN term
Dentine bonding agent/set
Device class
Class IIa EUDAMED
Class II GUDID
Regulation number
872.3275
EU registration type
Legacy device (under a directive)
EU market of registration
Germany
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: Dentine bonding agent/set

Cleared under the same submission (K053040)

Similar devices in this category

Other devices filed under DENTAL BONDING AGENTS.

Other devices from Coltène/Whaledent AG

See all devices from Coltène/Whaledent AG →

Properties

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