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UltraCal XS 1024

by Ultradent Products, Inc.

Ref 1024

UltraCal XS 1024 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 20 Jul 2026 (Basic UDI-DI 0883205-TF017AU), cleared under FDA 510(k) K970114 on 14 Mar 1997 and listed in FDA GUDID since 22 Sep 2016 (UDI-DI 00883205103987), 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) K970114

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-TF017AU Basic UDI-DI 00883205103987UDI-DIDate20 Jul 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number00883205103987 UDI-DI Date22 Sep 2016ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE GUDID from GUDID Substantially Equivalent · Traditional NumberK970114 Date14 Mar 1997DecidedStatusActive

Official records

Across registries

3 registries list this device

  • EUDAMED Basic UDI-DI 0883205-TF017AU registered 20 Jul 2026 Active
  • FDA 510(k) K970114 decided 14 Mar 1997 Active
  • FDA GUDID UDI-DI 00883205103987 listed 22 Sep 2016 Listed

Timeline

3 dated events

  1. Cleared FDA 510(k) K970114
  2. Listed FDA GUDID 00883205103987
  3. Registered EUDAMED 0883205-TF017AU

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  • Withdrawn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
UltraCal XS
Generic name
Calcium hydroxide dental suspension
Model / Ref / Catalog
1024
Primary DI / UDI-DI
00883205103987
Basic UDI-DI
0883205-TF017AU
510(k) Number
FDA product code
EJK
EMDN code
Q01010201 Root canal filling dental pastes
GMDN term
Calcium hydroxide dental suspension
Device class
Class IIa EUDAMED
Class II GUDID
Regulation number
872.3250
EU registration type
Standard device
EU market of registration
Germany
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 2 fields differ

FieldEUDAMEDGUDID
Device classEUDAMED
Class IIa
GUDID
Class II
ImplantableEUDAMED
Yes
GUDID
No

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: Calcium hydroxide dental suspension

Cleared under the same submission (K970114)

Similar devices in this category

Other devices filed under ROOT CANAL FILLING DENTAL PASTES.

Other devices from Ultradent Products, Inc.

See all devices from Ultradent Products, Inc. →

Properties

  • Implantable YesEUDAMEDNoGUDID
  • Prescription use
  • Convenience kit
  • Lot / batch number
  • Expiration date
Other properties (20, all answered No)