Identity
- Trade Name
- Endo-Eze MTAFlow EUDAMEDMTAFlow FDA UDI
- Generic Name
- Dental composite resin FDA UDI
- Device Name
- Endo-Eze MTA Flow EUDAMEDEndo-Eze MTAFlow Repair Cement Refill FDA UDI
- Model / Reference
- 3981 EUDAMEDFDA UDI
- Description
- Endo-Eze MTAFlow Repair Cement Refill FDA UDI
Identifiers
- Catalog Number
- 3981 FDA UDI
- Primary DI / UDI-DI
- 00883205004901 EUDAMEDFDA UDI
- Basic UDI-DI
- 0883205-REF39817T EUDAMED
- FDA Product Code
- KIF FDA UDI
- EMDN Code
- Q01010202 ROOT CANAL FILLING DENTAL CEMENTS EUDAMED
- GMDN Term
- Dental composite resin FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass II FDA UDI
- Regulation Number
- 872.3820 FDA UDI
- Medical Purpose
- Root Canal Fillings EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
No
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
Yes
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Dental composite resin
MTAFlow by Ultradent Products, Inc. — Class II — MDR, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
Similar devices
Also classified as Dental composite resin.
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- Llis — Dentscare Ltda · Class II
- Capo Universal, 6 g — Schütz Dental GmbH · Class II
- OMNICHROMA — TOKUYAMA DENTAL CORPORATION · Class II
- CLEARFIL MAJESTY ES Flow Universal Low (U) — Kuraray Noritake Dental Inc. Kurashiki · Class IIa
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Unknown
MDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDR | — | Class II | Unknown |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- Ultradent Products, Inc.
Sources (2)
- FDA UDI d2a87a68-dffc-4a0e-ba94-3abd08166eaf 35 fields · synced Jul 26, 2026
- EUDAMED 550ae53d-bdbf-40ea-b45d-a7ca3ab4ccb2 61 fields · synced Jul 26, 2026