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MTAFlow 3980-1

by Ultradent Products, Inc.

Ref 3980-1

MTAFlow 3980-1 is a dental composite resin (EU MDR Class IIa; FDA Class II; FDA product code KIF, Resin, Root Canal Filling) made by Ultradent Products, Inc., registered in EUDAMED on 28 May 2026 (Basic UDI-DI 0883205-REF3980-1BU) and listed in FDA GUDID since 5 Sep 2018 (UDI-DI 00883205029041), active as of 23 Oct 2026.

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

CE MDR

Valid until

No date given

EUDAMED holds no validity date

FDA recalls

Not checked

No FDA submission to match recalls against

Documents

None linked in EUDAMED

A group certificate may exist

Trust

Unverified

Source EUDAMED, GUDID, synced 23 Oct 2026.

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number0883205-REF3980-1BU Basic UDI-DI 00883205029041UDI-DIDate28 May 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number00883205029041 UDI-DI Date5 Sep 2018ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI 0883205-REF3980-1BU registered 28 May 2026 Active
  • FDA GUDID UDI-DI 00883205029041 listed 5 Sep 2018 Listed

Timeline

2 dated events

  1. Listed FDA GUDID 00883205029041
  2. Registered EUDAMED 0883205-REF3980-1BU

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  • Withdrawn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
Endo-Eze MTAFlow EUDAMED
MTAFlow GUDID
Generic name
Dental composite resin
Device name
Endo-Eze MTA Flow
Model / Ref / Catalog
3980-1
Primary DI / UDI-DI
00883205029041
Basic UDI-DI
0883205-REF3980-1BU
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
System or procedure pack
System
EU registration type
System or procedure pack
Medical purpose
Root Canal Fillings
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: Dental composite resin

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

  • Prescription use
  • Convenience kit
  • Lot / batch number
  • Expiration date
Other properties (11, all answered No)