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the wedge

by Polydentia SA 6 variants

Part of a family of 25 devices: see the family page

Ref 7012

the wedge (7012) is a Class I device made by Polydentia SA, registered in EUDAMED on 4 Nov 2021 (Basic UDI-DI ++E299PLASTICWEDGESXQ) and listed in FDA GUDID since 6 Jul 2022 (UDI-DI +E29970120), 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, self-declared

Class I: no certifier involved

Trust

Unverified

Source EUDAMED, GUDID, synced 22 Oct 2026.

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing GUDID Number+E29970120 UDI-DI Date6 Jul 2022ListedStatusListed GUDID: in commercial distribution
European UnionCE/MDR EUDAMED Number++E299PLASTICWEDGESXQ Basic UDI-DI +E29970120UDI-DIDate4 Nov 2021RegisteredStatusActive

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI ++E299PLASTICWEDGESXQ registered 4 Nov 2021 Active
  • FDA GUDID UDI-DI +E29970120 listed 6 Jul 2022 Listed

Certificates

0 certificates · EUDAMED

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

Timeline

2 dated events

  1. Registered EUDAMED ++E299PLASTICWEDGESXQ
  2. Listed FDA GUDID +E29970120

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  • Withdrawn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 wedge, single-use
Device name
Plastic Wedges
Model / reference
7012
Primary DI / UDI-DI
+E29970120 EUDAMED
E29970120 GUDID
Basic UDI-DI
++E299PLASTICWEDGESXQ
FDA product code
DZN
EMDN code
Q01010401 Paper and gutta-percha tips, matrices and wedges for dentistry
GMDN term
Dental wedge, single-use
Device class
Class I
Regulation number
872.4565
EU registration type
Standard device
EU market of registration
Liechtenstein
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 1 field differs

FieldEUDAMEDGUDID
Primary DI / UDI-DIEUDAMED
+E29970120
GUDID
E29970120

The registries describe this device under different primary UDI-DIs (EUDAMED lists +E29970120; FDA GUDID lists E29970120), 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 PAPER AND GUTTA-PERCHA TIPS, MATRICES AND WEDGES FOR DENTISTRY.

Other devices from Polydentia SA

See all devices from Polydentia SA →

Properties

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