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diamond24

by Polydentia SA

Part of a family of 37 devices: see the family page

Ref 6312

diamond24 (6312) is a Class I device made by Polydentia SA, registered in EUDAMED on 8 Nov 2021 (Basic UDI-DI ++E299DENTALRINGSM6) and listed in FDA GUDID since 7 Jul 2022 (UDI-DI +E29963120), 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+E29963120 UDI-DI Date7 Jul 2022ListedStatusListed GUDID: in commercial distribution
European UnionCE/MDR EUDAMED Number++E299DENTALRINGSM6 Basic UDI-DI +E29963120UDI-DIDate8 Nov 2021RegisteredStatusActive

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI ++E299DENTALRINGSM6 registered 8 Nov 2021 Active
  • FDA GUDID UDI-DI +E29963120 listed 7 Jul 2022 Listed

Timeline

2 dated events

  1. Registered EUDAMED ++E299DENTALRINGSM6
  2. Listed FDA GUDID +E29963120

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  • Withdrawn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 retainer
Device name
Dental Rings
Model / reference
6312
Primary DI / UDI-DI
+E29963120 EUDAMED
E29963120 GUDID
Basic UDI-DI
++E299DENTALRINGSM6
FDA product code
DZN
EMDN code
Q01010199 Dental restoration devices - other
GMDN term
Dental matrix band retainer
Device class
Class I
Regulation number
872.4565
EU registration type
Standard device
EU market of registration
Liechtenstein
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
+E29963120
GUDID
E29963120

The registries describe this device under different primary UDI-DIs (EUDAMED lists +E29963120; FDA GUDID lists E29963120), so their flags are not compared.

Manufacturer details

EUDAMED SRN
CH-MF-000008779
Authorised representative
IDD International Dental Distributors AG LI-AR-000008367

Similar devices in this category

Other devices filed under DENTAL RESTORATION DEVICES - OTHER.

Other devices from Polydentia SA

See all devices from Polydentia SA →

Properties

  • Sterilise before use
  • Premarket exempt
  • Lot / batch number
Other properties (22, all answered No)