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Synthetic Polymer Teeth SONNING

by Shandong Huge Dental Material Corporation EUDAMEDGUDID

Active European Union

Ref Sonning/T11/A2/6×1×16Model Upper anterior teeth, Lower anterior teeth, Posterior teeth

Regulatory status

as of 29 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number6909412RZY2A019J Basic UDI-DIDate3 Jun 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number06909412215665 UDI-DIDate26 Oct 2025ListedStatusListed GUDID: in commercial distribution

Coverage

2 jurisdictions

United States of AmericaSwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered
  • European Union CE/MDR Active
  • United States GUDID listing Listed

Certificates

0 certificates · EUDAMED

EUDAMED lists no certificate for this device's Basic UDI-DI.

A certificate issued for a device group may exist without being linked here.

Recalls

0 recalls · FDA

No FDA recalls on record, checked 25 Oct 2026.

Specification

EUDAMED · GUDID

Trade Name
Synthetic Polymer Teeth
Generic Name
Resin artificial teeth
Model / Ref / Catalog
Upper anterior teeth EUDAMED
Lower anterior teeth EUDAMED
Posterior teeth EUDAMED
Sonning/T11/A2/6×1×16 EUDAMED
SONNING GUDID
T11/A2/6×1×16 GUDID
Primary DI / UDI-DI
06909412215665
Basic UDI-DI
6909412RZY2A019J
510(k) Number
FDA Product Code
ELM
EMDN Code
Q01020601 Mobile dental prostheses
GMDN Term
Resin artificial teeth
Device Class
Class IIa EUDAMED
Class II GUDID
Regulation Number
872.3590
Market of Registration
Germany
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 2 fields differ

FieldEUDAMEDGUDID
Model / ReferenceEUDAMED
Upper anterior teeth, Lower anterior teeth, Posterior teeth
Sonning/T11/A2/6×1×16
GUDID
SONNING
Device ClassEUDAMED
Class IIa
GUDID
Class II

Related devices

Cleared under the same submission (K101029)

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Properties

  • Single Use
  • Prescription Use
  • Lot / Batch Number
  • Expiration Date

Other properties (20)

  • Sterile: No
  • Implantable: No
  • Reusable: No
  • Contains Latex: No
  • Reprocessed: No
  • CMR Substance: No
  • Human-derived: No
  • Human Tissues: No
  • Animal Tissues: No
  • Endocrine Disruptor: No
  • Administering Medicine: No
  • Measuring Function: No
  • Incorporates Medicinal Product: No
  • Over-the-Counter: No
  • Convenience Kit: No
  • Combination Product: No
  • HCT/P: No
  • Premarket Exempt: No
  • Serial Number: No
  • Manufacturing Date: No