Identity
- Trade Name
- MTA-FILLAPEX FDA UDI
- Generic Name
- Endodontic filling/sealing material FDA UDI
- Device Name
- Bioceramic Root Canal Sealer - MTA-Fillapex 4g MTA-Fillapex is a bioceramic root canal sealer based on MTA (mineral trioxide aggregate). Its composition provides long term sealing capacity, high radiopacity, promotes the stimulation of hard tissue formation in the dental apex and perforation sites, low expansion during setting, low solubility in contact with tissue fluids, excellent viscosity for insertion, does not stain the tooth, it is a eugenol-free material and has appropriate working time for endodontic procedures. FDA UDI
- Model / Reference
- MTA-Fillapex 4g FDA UDI
- Description
- Bioceramic Root Canal Sealer - MTA-Fillapex 4g MTA-Fillapex is a bioceramic root canal sealer based on MTA (mineral trioxide aggregate). Its composition provides long term sealing capacity, high radiopacity, promotes the stimulation of hard tissue formation in the dental apex and perforation sites, low expansion during setting, low solubility in contact with tissue fluids, excellent viscosity for insertion, does not stain the tooth, it is a eugenol-free material and has appropriate working time for endodontic procedures. FDA UDI
Identifiers
- Catalog Number
- 827 FDA UDI
- Primary DI / UDI-DI
- 07898078658277 FDA UDI
- FDA Product Code
- KIF FDA UDI
- GMDN Term
- Endodontic filling/sealing material FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 872.3820 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA 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
No
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: Endodontic filling/sealing material
Mta-Fillapex by Angelus Industria de Produtos Odontologicos S A — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Endodontic filling/sealing material.
- ACROSEAL TUBE — SEPTODONT SAS SPECIALITES SEPTODONT · Class II
- Pulp Canal Sealer — Ormco Corporation · Class II
- ROEKO GuttaFlow®2 — Coltène/Whaledent AG · Class I
- Midway Select — MIDWAY DENTAL SUPPLY, LLC · Class I
- Henry Schein — HENRY SCHEIN, INC. · Class II
- GIBSON — BENCO DENTAL SUPPLY CO. · Class II
- Midway Select — MIDWAY DENTAL SUPPLY, LLC · Class I
- DIA-ROOT BIO Sealer — DiaDent Group International · Class II
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- Angelus Industria de Produtos Odontologicos S A
Sources (1)
- FDA UDI 1d28b194-6667-470f-acf7-55dac304fb24 35 fields · synced May 30, 2026