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G-Wedge™ GWK4

by Garrison Dental Solutions, L.L.C.

Part of a family of 87 devices: see the family page

Ref GWK4

G-Wedge™ GWK4 is a Class I device made by Garrison Dental Solutions, L.L.C., registered in EUDAMED on 3 Apr 2026 (Basic UDI-DI 081003809WedgesTFZH) and listed in FDA GUDID since 24 Apr 2020 (UDI-DI 00810038095714), 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
European UnionCE/MDR EUDAMED Number081003809WedgesTFZH Basic UDI-DI 00810038095714UDI-DIDate3 Apr 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number00810038095714 UDI-DI Date24 Apr 2020ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI 081003809WedgesTFZH registered 3 Apr 2026 Active
  • FDA GUDID UDI-DI 00810038095714 listed 24 Apr 2020 Listed

Timeline

2 dated events

  1. Listed FDA GUDID 00810038095714
  2. Registered EUDAMED 081003809WedgesTFZH

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  • Withdrawn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

Trade name
G-Wedge™ Interproximal Wedge Kit EUDAMED
G-Wedge™ GUDID
Generic name
Dental wedge, single-use
Device name
Wedges Family
Model / Ref / Catalog
GWK4
Primary DI / UDI-DI
00810038095714
Basic UDI-DI
081003809WedgesTFZH
FDA product code
EJB
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
Germany
GUDID distribution status
In Commercial Distribution
Sterilisation method
Moist Heat or Steam Sterilization

Related devices

Category: Dental wedge, single-use

Similar devices in this category

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

Other devices from Garrison Dental Solutions LLC

See all devices from Garrison Dental Solutions LLC →

Properties

  • Sterilise before use
  • Single use
  • Prescription use
  • Premarket exempt
  • Lot / batch number
  • Manufacturing date
Other properties (19, all answered No)