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MIRIS2 8443

by Coltène/Whaledent AG

Ref 8443Model MIRIS 2

MIRIS2 8443 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-J00684430), cleared under FDA 510(k) K974465 on 9 Mar 1998 and listed in FDA GUDID since 15 Aug 2016 (UDI-DI J00684430), 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) K974465

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-J00684430 Basic UDI-DI J00684430UDI-DIDate26 Oct 2026RegisteredStatusActive
United StatesGUDID listing GUDID NumberJ00684430 UDI-DI Date15 Aug 2016ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE GUDID from GUDID Substantially Equivalent · Traditional NumberK974465 Date9 Mar 1998DecidedStatusActive

Official records

Across registries

3 registries list this device

  • EUDAMED Basic UDI-DI B-J00684430 registered 26 Oct 2026 Active
  • FDA 510(k) K974465 decided 9 Mar 1998 Active
  • FDA GUDID UDI-DI J00684430 listed 15 Aug 2016 Listed

Timeline

3 dated events

  1. Cleared FDA 510(k) K974465
  2. Listed FDA GUDID J00684430
  3. Registered EUDAMED B-J00684430

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  • Withdrawn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
Miris Enamel Ir Sgl EUDAMED
MIRIS2 GUDID
Generic name
Dental veneer, professional
Model / Ref / Catalog
8443, MIRIS 2
Primary DI / UDI-DI
J00684430
Basic UDI-DI
B-J00684430
510(k) Number
FDA product code
EBF
EMDN code
Q01010103 Dental restorative composites
GMDN term
Dental veneer, professional
Device class
Class IIa EUDAMED
Class II GUDID
Regulation number
872.3690
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: Dental veneer, professional

Cleared under the same submission (K974465)

and 8 more cleared under K974465

Similar devices in this category

Other devices filed under DENTAL RESTORATIVE COMPOSITES.

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)