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F-Splint-Aid

by Polydentia SA

Ref 5972

F-Splint-Aid (5972) is a device classified as Class IIa in the EU and Class II in the US made by Polydentia SA, registered in EUDAMED on 8 Nov 2021 (Basic UDI-DI B-+E29959720), cleared under FDA 510(k) K962374 on 22 Jul 1996 and listed in FDA GUDID since 28 Sep 2016 (UDI-DI +E29959720), withdrawn (EUDAMED), active (FDA 510(k)) as of 23 Oct 2026.

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 Withdrawn in European Union.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

CE MDD, withdrawn 510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 23 Oct 2026

Documents

None linked in EUDAMED

A group certificate may exist

510(k) K962374

FDA submission, from GUDID

Trust

Unverified

Source EUDAMED, GUDID, synced 23 Oct 2026.

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDD EUDAMED NumberB-+E29959720 Basic UDI-DI +E29959720UDI-DIDate8 Nov 2021RegisteredStatusWithdrawn No longer placed on the EU market
United StatesGUDID listing GUDID Number+E29959720 UDI-DI Date28 Sep 2016ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE GUDID from GUDID Substantially Equivalent · Traditional NumberK962374 Date22 Jul 1996DecidedStatusActive

Official records

Across registries

3 registries list this device

  • EUDAMED Basic UDI-DI B-+E29959720 registered 8 Nov 2021 Withdrawn
  • FDA 510(k) K962374 decided 22 Jul 1996 Active
  • FDA GUDID UDI-DI +E29959720 listed 28 Sep 2016 Listed

Timeline

3 dated events

  1. Cleared FDA 510(k) K962374
  2. Listed FDA GUDID +E29959720
  3. Registered EUDAMED B-+E29959720

Coverage

2 jurisdictions

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  • Withdrawn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  • European Union CE/MDD Withdrawn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

Specification

EUDAMED · GUDID

Generic name
Dental reinforcing fibre
Model / reference
5972
Primary DI / UDI-DI
+E29959720 EUDAMED
E29959720 GUDID
Basic UDI-DI
B-+E29959720
510(k) Number
FDA product code
EBI
EMDN code
Q010199 Conservative dentistry and endodontics devices - other
GMDN term
Dental reinforcing fibre
Device class
Class IIa EUDAMED
Class II GUDID
Regulation number
872.3760
EU registration type
Legacy device (under a directive)
EU market of registration
Liechtenstein
GUDID distribution status
In Commercial Distribution
MRI safety
MR Safe

Truth per registry

2 sources · 2 fields differ

FieldEUDAMEDGUDID
Primary DI / UDI-DIEUDAMED
+E29959720
GUDID
E29959720
Device classEUDAMED
Class IIa
GUDID
Class II

The registries describe this device under different primary UDI-DIs (EUDAMED lists +E29959720; FDA GUDID lists E29959720), so their flags are not compared. Device class is stated on each registry's own scale: Class IIa in the EU (EUDAMED), Class II in the US (FDA GUDID). EU and US classes are different schemes, so this is not a disagreement.

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 CONSERVATIVE DENTISTRY AND ENDODONTICS DEVICES - OTHER.

Other devices from Polydentia SA

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Properties

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