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Fiber-bond 1x5ml 6525

by Polydentia SA

Fiber-bond 1x5ml 6525 is a Class II device made by Polydentia SA, cleared under FDA 510(k) K962374 on 22 Jul 1996, registered in EUDAMED and listed in FDA GUDID since 28 Sep 2016 (UDI-DI E29965250), active as of 22 Oct 2026.

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

CE MDD 510(k)

Valid until

No date given

CE: no date in EUDAMED. FDA: 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) K962374

FDA submission, from GUDID

Trust

Unverified

Source EUDAMED, GUDID, synced 22 Oct 2026.

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing GUDID NumberE29965250 UDI-DI Date28 Sep 2016ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE GUDID from GUDID Substantially Equivalent · Traditional NumberK962374 Date22 Jul 1996DecidedStatusActive
European UnionCE/MDD EUDAMED Number— Date—StatusActive

Official records

Across registries

3 registries list this device

  • FDA 510(k) K962374 decided 22 Jul 1996 Active
  • EUDAMED Active
  • FDA GUDID UDI-DI E29965250 listed 28 Sep 2016 Listed

Timeline

2 dated events

  1. Cleared FDA 510(k) K962374
  2. Listed FDA GUDID E29965250

Coverage

2 jurisdictions

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  • Withdrawn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

Specification

EUDAMED · GUDID

Trade name
Fiber-bond 1x5ml
Generic name
Dentine bonding agent/set
Model / reference
6525
Primary DI / UDI-DI
E29965250
510(k) Number
FDA product code
EBI
GMDN term
Dentine bonding agent/set
Device class
Class II
Regulation number
872.3760
GUDID distribution status
In Commercial Distribution
MRI safety
MR Safe

Related devices

Category: Dentine bonding agent/set

Cleared under the same submission (K962374)

and 2 more cleared under K962374

Similar devices in this category

Other devices filed under Dentine bonding agent/set.

Other devices from Polydentia SA

See all devices from Polydentia SA →

Properties

  • Single use
  • Lot / batch number
  • Expiration date
  • Manufacturing date
Other properties (11, all answered No)