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EndoREZ Points 1634

by Ultradent Products, Inc.

Ref 5900

Active European Union. Also listed in GUDID (US).

CE MDR

Valid until

Not listed

EUDAMED holds no validity date

FDA recalls

None found

in data synced 23 Oct 2026

Documents

None linked in EUDAMED

A group certificate may exist

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, GUDID, synced 23 Oct 2026. What this means

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number0883205-TF121AQ Basic UDI-DI 00883205106803UDI-DIDate29 May 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number00883205106803 UDI-DI Date7 Feb 2018ListedStatusListed GUDID: in commercial distribution

Certificates

0 certificates · EUDAMED

EUDAMED lists no certificate for this device's Basic UDI-DI.

A certificate issued for a device group may exist without being linked here.

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 23 Oct 2026.

Coverage

2 jurisdictions

United States of AmericaSwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered
  • European Union CE/MDR Active
  • United States GUDID listing Listed

Specification

EUDAMED · GUDID

Trade Name
EndoREZ EUDAMEDGUDID
EndoREZ Points GUDID
Generic Name
Natural gutta-percha
Dental composite resin
Model / Ref / Catalog
5900, 1634
Primary DI / UDI-DI
00883205106803, 00883205020093
Basic UDI-DI
0883205-TF121AQ
FDA Product Code
EKM, KIF
EMDN Code
Q01010202 Root canal filling dental cements
GMDN Term
Natural gutta-percha
Dental composite resin
Device Class
Class IIa EUDAMED
Class I GUDID
Class II GUDID
Regulation Number
872.3850, 872.3820
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 I
Class II
ImplantableEUDAMED
Yes
GUDID
No

Related devices

Category: Natural gutta-percha

Other devices from Ultradent Products, Inc.

See all devices from Ultradent Products, Inc. →

Properties

  • Single Use YesGUDIDNoGUDID
  • Implantable YesEUDAMEDNoGUDID
  • Prescription Use
  • Convenience Kit NoGUDIDYesGUDID
  • Premarket Exempt YesGUDIDNoGUDID
  • Lot / Batch Number
  • Expiration Date

Other properties (17)

  • Sterile: No
  • Reusable: No
  • Contains Latex: No
  • Reprocessed: No
  • CMR Substance: No
  • Human-derived: No
  • Human Tissues: No
  • Animal Tissues: No
  • Endocrine Disruptor: No
  • Administering Medicine: No
  • Measuring Function: No
  • Incorporates Medicinal Product: No
  • Over-the-Counter: No
  • Combination Product: No
  • HCT/P: No
  • Serial Number: No
  • Manufacturing Date: No