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One Coat 7.0 7054

by Coltène/Whaledent AG

Ref 7054Model ONE COAT 7 Activator

One Coat 7.0 7054 is a dentine bonding agent/set (EU MDD Class IIa; FDA Class II; FDA product code KLE, Agent, Tooth Bonding, Resin) made by Coltène/Whaledent AG, registered in EUDAMED on 26 Oct 2026 (Basic UDI-DI B-J00670540), cleared under FDA 510(k) K152243 on 9 Dec 2015 and listed in FDA GUDID since 15 Aug 2016 (UDI-DI J00670540), 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) K152243

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-J00670540 Basic UDI-DI J00670540UDI-DIDate26 Oct 2026RegisteredStatusActive
United StatesGUDID listing GUDID NumberJ00670540 UDI-DI Date15 Aug 2016ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE GUDID from GUDID Substantially Equivalent · Traditional NumberK152243 Date9 Dec 2015DecidedStatusActive

Official records

Across registries

3 registries list this device

  • EUDAMED Basic UDI-DI B-J00670540 registered 26 Oct 2026 Active
  • FDA 510(k) K152243 decided 9 Dec 2015 Active
  • FDA GUDID UDI-DI J00670540 listed 15 Aug 2016 Listed

Timeline

3 dated events

  1. Cleared FDA 510(k) K152243
  2. Listed FDA GUDID J00670540
  3. Registered EUDAMED B-J00670540

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  • Withdrawn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
One Coat 7.0 Activator Ref. EUDAMED
One Coat 7.0 GUDID
Generic name
Dentine bonding agent/set
Model / Ref / Catalog
7054, ONE COAT 7 Activator
Primary DI / UDI-DI
J00670540
Basic UDI-DI
B-J00670540
510(k) Number
FDA product code
KLE
EMDN code
Q01010104 Dental bonding agents
GMDN term
Dentine bonding agent/set
Device class
Class IIa EUDAMED
Class II GUDID
Regulation number
872.3200
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 (K152243)

and 1 more cleared under K152243

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)