Skip to content

PermaFlo DC 1318

by Ultradent Products, Inc.

Part of a family of 7 devices: see the family page

Ref 5914, 1005, 956

PermaFlo DC 1318 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) K974413 on 2 Feb 1998 (1 earlier submission) and listed in FDA GUDID since 22 Sep 2016 (UDI-DI 00883205103871), active as of 23 Oct 2026. One FDA recall is linked to it.

Active European Union and United States. Also listed in GUDID (US), partly in commercial distribution.

CE MDR 510(k)

Valid until

No date given

CE: no date in EUDAMED. FDA: not time-limited

FDA recalls

None ongoing

1 closed

Documents

None linked in EUDAMED

A group certificate may exist

510(k) K974413

+1 more

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 Date21 May 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number00883205103871 UDI-DI Date22 Sep 2016ListedStatusListed GUDID: 3 of 4 UDI-DIs in commercial distribution
United StatesFDA 510(k)SESE GUDID from GUDID Substantially Equivalent · Traditional NumberK974413 Date2 Feb 1998DecidedStatusActive

Official records

Across registries

3 registries list this device

  • EUDAMED Basic UDI-DI 0883205-TF007AR registered 21 May 2026 Active
  • FDA 510(k) K974413 decided 2 Feb 1998 Active· +1 more in the status table
  • FDA GUDID UDI-DI 00883205103871 listed 22 Sep 2016 Listed

Recalls

1 recall · FDA

    • Terminated Z-0053-2021 FDA Class II initiated 31 Aug 2020

    Due to a potential manufacturing issue (cross contamination), composite is non-homogeneous.

Timeline

5 dated events

  1. Cleared FDA 510(k) K960696
  2. Cleared FDA 510(k) K974413
  3. Listed FDA GUDID 00883205103871
  4. Recall initiated FDA recalls Z-0053-2021
  5. 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  • Withdrawn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
PermaFlo
Generic name
Dental composite resin
Dentine adhesive
Model / Ref / Catalog
956, 1005, 5914, 1318
Primary DI / UDI-DI
00883205103871, 00883205104052, 00883205106834, 00883205106223
Basic UDI-DI
0883205-TF007AR, 0883205-TF006AP
510(k) Number
FDA product code
KLE, EBF
EMDN code
Q0101010201, Q01010103
GMDN term
Dental composite resin
Dentine adhesive
Device class
Class IIa EUDAMED
Class II GUDID
Regulation number
872.3200, 872.3690
EU registration type
Standard device
EU market of registration
Germany
GUDID distribution status
Not in Commercial Distribution (UDI-DI 00883205106223)
In Commercial Distribution (UDI-DI 00883205103871, 00883205104052, 00883205106834)

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

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)