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EndoREZ S2740

by Ultradent Products, Inc.

Ref S2740

EndoREZ S2740 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 29 May 2026 (Basic UDI-DI 0883205-TF121AQ), cleared under FDA 510(k) K042756 on 26 Oct 2004 and listed in FDA GUDID since 22 Sep 2016 (UDI-DI 00883205102768), 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) K042756

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-TF121AQ Basic UDI-DI 00883205102768UDI-DIDate29 May 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number00883205102768 UDI-DI Date22 Sep 2016ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE GUDID from GUDID Substantially Equivalent · Special NumberK042756 Date26 Oct 2004DecidedStatusActive

Official records

Across registries

3 registries list this device

  • EUDAMED Basic UDI-DI 0883205-TF121AQ registered 29 May 2026 Active
  • FDA 510(k) K042756 decided 26 Oct 2004 Active
  • FDA GUDID UDI-DI 00883205102768 listed 22 Sep 2016 Listed

Timeline

3 dated events

  1. Cleared FDA 510(k) K042756
  2. Listed FDA GUDID 00883205102768
  3. Registered EUDAMED 0883205-TF121AQ

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  • Withdrawn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
EndoREZ
Generic name
Dental composite resin
Model / Ref / Catalog
S2740
Primary DI / UDI-DI
00883205102768
Basic UDI-DI
0883205-TF121AQ
FDA product code
KIF
EMDN code
Q01010202 Root canal filling dental cements
GMDN term
Dental composite resin
Device class
Class IIa EUDAMED
Class II GUDID
Regulation number
872.3820
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: Endodontic filling/sealing material

Cleared under the same submission (K042756)

Similar devices in this category

Other devices filed under ROOT CANAL FILLING DENTAL CEMENTS.

Other devices from Ultradent Products, Inc.

See all devices from Ultradent Products, Inc. →

Properties

  • Single use
  • Implantable YesEUDAMEDNoGUDID
  • Prescription use
  • Convenience kit
  • Lot / batch number
  • Expiration date
Other properties (19, all answered No)