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Kenson T10B1L0050

by The Myerson Company Limited

Ref T10B1L0050

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 22 Oct 2026

Documents

2 certificates

Certifier Intertek Medical Notified Body AB

510(k) K924526

FDA submission, from GUDID

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, GUDID, synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number08423261TeethXK Basic UDI-DI 00842326113756UDI-DIDate19 Nov 2025RegisteredStatusActive
United StatesGUDID listing GUDID Number00842326113756 UDI-DI Date24 Sep 2016ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE GUDID from GUDID Substantially Equivalent · Traditional NumberK924526 Date4 Nov 1992DecidedStatusActive

Certificates

2 certificates · EUDAMED

EUDAMED certificates (2)

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 22 Oct 2026.

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  • Withdrawn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
Kenson
Generic name
Resin artificial teeth
Device name
Preformed Artificial Teeth
Model / reference
T10B1L0050
Primary DI / UDI-DI
00842326113756
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)

Show all (12)

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)

  • Supplied sterile: No
  • Sterilise before use: No
  • Single use: No
  • Reusable: No
  • Contains latex: No
  • Reprocessed single-use device: No
  • Contains CMR substances (carcinogenic, mutagenic or toxic to reproduction): No
  • Incorporates a substance derived from human blood or plasma: No
  • Contains human tissues or cells: No
  • Contains animal tissues or cells: No
  • Contains endocrine-disrupting substances: No
  • Administering medicine: No
  • Measuring function: No
  • Incorporates a medicinal substance: No
  • Over-the-counter: No
  • Convenience kit: No
  • Combination product: No
  • HCT/P: No
  • Premarket exempt: No
  • Serial number: No
  • Expiration date: No
  • Manufacturing date: No