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Myerson db plus T34D4L0F31

by The Myerson Company Limited

Ref T34D4L0F31

Myerson db plus T34D4L0F31 is a device classified as Class IIa in the EU and Class II in the US made by The Myerson Company Limited, registered in EUDAMED on 19 Nov 2025 (Basic UDI-DI 08423261TeethXK) with CE/MDR certificate 28620225594 valid until 16 Oct 2030, cleared under FDA 510(k) K924526 on 4 Nov 1992 and listed in FDA GUDID since 24 Sep 2016 (UDI-DI 00842326139756), active as of 25 Oct 2026.

Active European Union and United States. Also listed in GUDID (US).

CE MDR 510(k)

Valid until

16 Oct 2030

CE MDR certificate

FDA recalls

None found

in data synced 25 Oct 2026

Documents

2 certificates

Certifier Intertek Medical Notified Body AB

510(k) K924526

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/MDR EUDAMED Number08423261TeethXK Basic UDI-DI 00842326139756UDI-DIDate19 Nov 2025RegisteredStatusActive
United StatesGUDID listing GUDID Number00842326139756 UDI-DI Date24 Sep 2016ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE GUDID from GUDID Substantially Equivalent · Traditional NumberK924526 Date4 Nov 1992DecidedStatusActive

Official records

Across registries

3 registries list this device

  • EUDAMED Basic UDI-DI 08423261TeethXK registered 19 Nov 2025 Active· +1 more in the status table
  • FDA 510(k) K924526 decided 4 Nov 1992 Active
  • FDA GUDID UDI-DI 00842326139756 listed 24 Sep 2016 Listed

Certificates

2 certificates · EUDAMED

EUDAMED certificates (2)

Timeline

5 dated events

  1. Cleared FDA 510(k) K924526
  2. Listed FDA GUDID 00842326139756
  3. Certificate issued EUDAMED 28620225594
  4. Registered EUDAMED 08423261TeethXK
  5. Certificate expires EUDAMED 28620225594

Coverage

2 jurisdictions

United States of AmericaSwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered
  • European Union CE/MDR Active
  • United States FDA 510(k) Active

Specification

EUDAMED · GUDID

Trade name
Myerson DB Plus Composite EUDAMED
Myerson db plus GUDID
Generic name
Resin artificial teeth
Device name
Preformed Artificial Teeth
Model / reference
T34D4L0F31
Primary DI / UDI-DI
00842326139756
Basic UDI-DI
08423261TeethXK
510(k) Number
FDA product code
ELM
EMDN code
P01020101 Dental implants
GMDN term
Resin artificial teeth
Device class
Class IIa EUDAMED
Class II GUDID
Regulation number
872.3590
EU registration type
Standard device
EU market of registration
France
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

Related devices

Category: Resin artificial teeth

Cleared under the same submission (K924526)

and 8 more cleared under K924526

Other devices from The Myerson Company Limited

See all devices from The Myerson Company Limited →

Properties

  • Implantable YesEUDAMEDNoGUDID
  • Prescription use
  • Lot / batch number
Other properties (22, all answered No)