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myQuickmat All-round introkit

by Polydentia SA

Ref 6850

myQuickmat All-round introkit (6850) is a dental matrix band kit (EU MDR Class I; FDA Class I; FDA product code DZN, Instruments, Dental Hand) made by Polydentia SA, registered in EUDAMED on 28 Oct 2021 (Basic UDI-DI ++E299MQARIK8E) and listed in FDA GUDID since 1 Apr 2022 (UDI-DI +E29968500), active as of 22 Oct 2026.

Active European Union. Also listed in GUDID (US).

CE MDR

Valid until

No date given

EUDAMED holds no validity date

FDA recalls

Not checked

No FDA submission to match recalls against

Documents

None linked in EUDAMED

A group certificate may exist

Trust

Unverified

Source EUDAMED, GUDID, synced 22 Oct 2026.

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing GUDID Number+E29968500 UDI-DI Date1 Apr 2022ListedStatusListed GUDID: in commercial distribution
European UnionCE/MDR EUDAMED Number++E299MQARIK8E Basic UDI-DI +E29968500UDI-DIDate28 Oct 2021RegisteredStatusActive

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI ++E299MQARIK8E registered 28 Oct 2021 Active
  • FDA GUDID UDI-DI +E29968500 listed 1 Apr 2022 Listed

Timeline

2 dated events

  1. Registered EUDAMED ++E299MQARIK8E
  2. Listed FDA GUDID +E29968500

Coverage

2 jurisdictions

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  • Withdrawn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

Specification

EUDAMED · GUDID

Generic name
Dental matrix band kit
Model / reference
6850
Primary DI / UDI-DI
+E29968500 EUDAMED
E29968500 GUDID
Basic UDI-DI
++E299MQARIK8E
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
System or procedure pack
Procedure pack
EU registration type
System or procedure pack
Medical purpose
Circumferential matrix system for posterior dental restorations
GUDID distribution status
In Commercial Distribution
Sterilisation method
Moist Heat or Steam Sterilization

Truth per registry

2 sources · 2 fields differ

FieldEUDAMEDGUDID
Primary DI / UDI-DIEUDAMED
+E29968500
GUDID
E29968500
Sterilise before useEUDAMED
No
GUDID
Yes

The registries describe this device under different primary UDI-DIs (EUDAMED lists +E29968500; FDA GUDID lists E29968500), so their flags are not compared.

Manufacturer details

EUDAMED SRN
CH-PR-000009114

Similar devices in this category

Other devices filed under PAPER AND GUTTA-PERCHA TIPS, MATRICES AND WEDGES FOR DENTISTRY.

Other devices from Polydentia SA

See all devices from Polydentia SA →

Properties

  • Sterilise before use NoEUDAMEDYesGUDID
  • Premarket exempt
  • Lot / batch number
Other properties (12, all answered No)