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PermaFlo DC 5912

by Ultradent Products, Inc.

Ref 5912

PermaFlo DC 5912 is a device classified as Class IIa in the EU and Class II in the US made by Ultradent Products, Inc., registered in EUDAMED on 21 May 2026 (Basic UDI-DI 0883205-TF007AR), cleared under FDA 510(k) K960696 on 18 Jul 1996 and listed in FDA GUDID since 22 Sep 2016 (UDI-DI 00883205106810), active as of 23 Oct 2026.

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

CE MDR 510(k)

Valid until

No date given

CE: no date in EUDAMED. FDA: 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) K960696

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/MDR EUDAMED Number0883205-TF007AR Basic UDI-DI 00883205106810UDI-DIDate21 May 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number00883205106810 UDI-DI Date22 Sep 2016ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE GUDID from GUDID Substantially Equivalent · Traditional NumberK960696 Date18 Jul 1996DecidedStatusActive

Official records

Across registries

3 registries list this device

  • EUDAMED Basic UDI-DI 0883205-TF007AR registered 21 May 2026 Active
  • FDA 510(k) K960696 decided 18 Jul 1996 Active
  • FDA GUDID UDI-DI 00883205106810 listed 22 Sep 2016 Listed

Timeline

3 dated events

  1. Cleared FDA 510(k) K960696
  2. Listed FDA GUDID 00883205106810
  3. Registered EUDAMED 0883205-TF007AR

Coverage

2 jurisdictions

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  • Withdrawn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

Specification

EUDAMED · GUDID

Trade name
PermaFlo DC
Generic name
Dentine adhesive
Model / Ref / Catalog
5912
Primary DI / UDI-DI
00883205106810
Basic UDI-DI
0883205-TF007AR
510(k) Number
FDA product code
KLE
EMDN code
Q0101010201 Dental base cements
GMDN term
Dentine adhesive
Device class
Class IIa EUDAMED
Class II GUDID
Regulation number
872.3200
EU registration type
Standard device
EU market of registration
Germany
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 1 field differs

FieldEUDAMEDGUDID
Device classEUDAMED
Class IIa
GUDID
Class II

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.

Related devices

Category: Dentine adhesive

Cleared under the same submission (K960696)

Similar devices in this category

Other devices filed under DENTAL BASE CEMENTS.

Other devices from Ultradent Products, Inc.

See all devices from Ultradent Products, Inc. →

Properties

  • Prescription use
  • Convenience kit
  • Lot / batch number
  • Expiration date
Other properties (21, all answered No)