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Maximat plus kit

by Polydentia SA

Ref 5190

Maximat plus kit (5190) is a Class I device made by Polydentia SA, registered in EUDAMED on 8 Nov 2021 (Basic UDI-DI ++E299MPIVG) and listed in FDA GUDID since 1 Apr 2022 (UDI-DI +E29951900), withdrawn as of 22 Oct 2026.

Withdrawn Withdrawn in European Union. No longer placed on the EU market.

Was authorized under CE MDR, withdrawn

Ended

Withdrawn

Date not published (CE MDR)

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+E29951900 UDI-DI Date1 Apr 2022ListedStatusListed GUDID: in commercial distribution
European UnionCE/MDR EUDAMED Number++E299MPIVG Basic UDI-DI +E29951900UDI-DIDate8 Nov 2021RegisteredStatusWithdrawn No longer placed on the EU market

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI ++E299MPIVG registered 8 Nov 2021 Withdrawn
  • FDA GUDID UDI-DI +E29951900 listed 1 Apr 2022 Listed

Timeline

2 dated events

  1. Registered EUDAMED ++E299MPIVG
  2. Listed FDA GUDID +E29951900

Coverage

2 jurisdictions

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  • Withdrawn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  • European Union CE/MDR Withdrawn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

Specification

EUDAMED · GUDID

Generic name
Dental matrix band kit
Model / reference
5190
Primary DI / UDI-DI
+E29951900 EUDAMED
E29951900 GUDID
Basic UDI-DI
++E299MPIVG
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 matrices for posterior dental restorations
GUDID distribution status
In Commercial Distribution
Sterilisation method
Moist Heat or Steam Sterilization

Truth per registry

2 sources · 1 field differs

FieldEUDAMEDGUDID
Primary DI / UDI-DIEUDAMED
+E29951900
GUDID
E29951900

The registries describe this device under different primary UDI-DIs (EUDAMED lists +E29951900; FDA GUDID lists E29951900), 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
  • Premarket exempt
  • Lot / batch number
Other properties (12, all answered No)