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Contact Matrix System 89439

by Zest Anchors, LLC EUDAMEDGUDID

Active European Union

Ref 89439

Regulatory status

as of 29 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number081659402D05239 Basic UDI-DIDate2 Oct 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number00816594025714 UDI-DIDate1 Oct 2026ListedStatusListed 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  • Withdrawn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

No notified-body certificate is listed. Devices of this class are self-declared by the manufacturer.

Recalls

0 recalls · FDA

No FDA recalls on record, checked 25 Oct 2026.

Specification

EUDAMED · GUDID

Trade Name
Contact Matrix EUDAMED
Contact Matrix System GUDID
Generic Name
Dental matrix band kit
Model / Reference
89439
Primary DI / UDI-DI
00816594025714
Basic UDI-DI
081659402D05239
FDA Product Code
DZN
EMDN Code
Q01010401 Paper and gutta-percha tips, matrices and wedges for dentistry
GMDN Term
Dental matrix band kit
Device Class
Class I
Regulation Number
872.4565
Medical Purpose
Kits for use with the Contact Matrix Systems.
GUDID distribution status
In Commercial Distribution

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Properties

  • Single Use
  • Prescription Use
  • Convenience Kit
  • Premarket Exempt
  • Lot / Batch Number
  • Manufacturing Date

Other properties (8)

  • Sterile: No
  • Implantable: No
  • Contains Latex: No
  • Over-the-Counter: No
  • Combination Product: No
  • HCT/P: No
  • Serial Number: No
  • Expiration Date: No