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myJunior kit

by Polydentia SA

Ref 6330

myJunior kit (6330) 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 10 Nov 2021 (Basic UDI-DI ++E299MJKV2) and listed in FDA GUDID since 1 Apr 2022 (UDI-DI +E29963300), 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+E29963300 UDI-DI Date1 Apr 2022ListedStatusListed GUDID: in commercial distribution
European UnionCE/MDR EUDAMED Number++E299MJKV2 Basic UDI-DI +E29963300UDI-DIDate10 Nov 2021RegisteredStatusActive

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI ++E299MJKV2 registered 10 Nov 2021 Active
  • FDA GUDID UDI-DI +E29963300 listed 1 Apr 2022 Listed

Timeline

2 dated events

  1. Registered EUDAMED ++E299MJKV2
  2. Listed FDA GUDID +E29963300

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  • Withdrawn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
6330
Primary DI / UDI-DI
+E29963300 EUDAMED
E29963300 GUDID
Basic UDI-DI
++E299MJKV2
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
Sectional matrix system for paediatric dentistry
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
+E29963300
GUDID
E29963300

The registries describe this device under different primary UDI-DIs (EUDAMED lists +E29963300; FDA GUDID lists E29963300), 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
  • Expiration date
Other properties (11, all answered No)