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A+Wedge® GWAS01

by Garrison Dental Solutions, L.L.C.

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

Ref GWAS01

A+Wedge GWAS01 is a dental wedge (EU MDR Class I; FDA Class I; FDA product code EJB, Handle, Instrument, Dental) made by Garrison Dental Solutions, L.L.C., registered in EUDAMED on 3 Apr 2026 (Basic UDI-DI 081003809WedgesTFZH), cleared under FDA 510(k) K140144 on 8 Jul 2014 and listed in FDA GUDID since 24 Apr 2020 (UDI-DI 00810038095691), withdrawn (EUDAMED), active (FDA 510(k)) as of 22 Oct 2026.

Active Active in United States. Withdrawn in European Union. Also listed in GUDID (US).

CE MDR, withdrawn 510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 22 Oct 2026

Documents

None linked in EUDAMED

A group certificate may exist

510(k) K140144

FDA submission, from GUDID

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 00810038095691UDI-DIDate3 Apr 2026RegisteredStatusWithdrawn
United StatesGUDID listing GUDID Number00810038095691 UDI-DI Date24 Apr 2020ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE GUDID from GUDID Substantially Equivalent · Traditional NumberK140144 Date8 Jul 2014DecidedStatusActive

Official records

Across registries

3 registries list this device

  • EUDAMED Basic UDI-DI 081003809WedgesTFZH registered 3 Apr 2026 Withdrawn
  • FDA 510(k) K140144 decided 8 Jul 2014 Active
  • FDA GUDID UDI-DI 00810038095691 listed 24 Apr 2020 Listed

Timeline

3 dated events

  1. Cleared FDA 510(k) K140144
  2. Listed FDA GUDID 00810038095691
  3. Registered EUDAMED 081003809WedgesTFZH

Coverage

2 jurisdictions

United States of AmericaSwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered
  • European Union CE/MDR Withdrawn
  • United States FDA 510(k) Active

Specification

EUDAMED · GUDID

Trade name
A+ Wedge™ Astringent Interproximal Wedge Kit EUDAMED
A+Wedge® GUDID
Generic name
Dental wedge, single-use
Device name
Wedges Family
Model / Ref / Catalog
GWAS01
Description
Wedge Sample Kit: 50 Count (25) X-Small Yellow, (25) Small Blue
Primary DI / UDI-DI
00810038095691
Basic UDI-DI
081003809WedgesTFZH
510(k) Number
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

Cleared under the same submission (K140144)

and 2 more cleared under K140144

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
  • Lot / batch number
  • Expiration date
  • Manufacturing date
Other properties (19, all answered No)