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FitStrip™ FPSXFDS

by Garrison Dental Solutions, L.L.C.

Ref FPSXFDS

FitStrip™ FPSXFDS is a Class I device made by Garrison Dental Solutions, L.L.C., registered in EUDAMED on 12 May 2026 (Basic UDI-DI 081003809PolishersTFAC) and listed in FDA GUDID since 24 Apr 2020 (UDI-DI 00810038094137), active as of 25 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 25 Oct 2026.

Regulatory status

as of registry sync 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number081003809PolishersTFAC Basic UDI-DI 00810038094137UDI-DIDate12 May 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number00810038094137 UDI-DI Date24 Apr 2020ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI 081003809PolishersTFAC registered 12 May 2026 Active
  • FDA GUDID UDI-DI 00810038094137 listed 24 Apr 2020 Listed

Timeline

2 dated events

  1. Listed FDA GUDID 00810038094137
  2. Registered EUDAMED 081003809PolishersTFAC

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  • Withdrawn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
FitStrip™ Interproximal Finishing & Contouring EUDAMED
FitStrip™ GUDID
Generic name
Dental abrasive strip, single-use
Device name
Polishers & Abrasives Family
Model / Ref / Catalog
FPSXFDS
Primary DI / UDI-DI
00810038094137
Basic UDI-DI
081003809PolishersTFAC
FDA product code
DZP
EMDN code
Q01010403 Dental abrasive and polishing materials
GMDN term
Dental abrasive strip, single-use
Device class
Class I
Regulation number
872.4535
System or procedure pack
Procedure pack which is a device in itself
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 abrasive strip, single-use

Similar devices in this category

Other devices filed under DENTAL PROCEDURE DEVICES - VARIOUS.

Other devices from Garrison Dental Solutions LLC

See all devices from Garrison Dental Solutions LLC →

Properties

  • Sterilise before use
  • Prescription use
  • Premarket exempt
  • Lot / batch number
  • Manufacturing date
Other properties (20, all answered No)