Identity
- Trade Name
- PD MTA White FDA UDI
- Generic Name
- Endodontic filling/sealing material FDA UDI
- Device Name
- PD MTA White is a radiopaque root canal repair material material. The material composed of several mineral oxides is made up of thin hydrophilic particles showing the following advantages : – Optimized particle size allowing homogeneous and complete wetting during mixing – Avoids bacterial migration and penetration of tissue fluids into the root canal thanks to its excellent marginal sealing capacity – No need to dry the treated site. PD MTA White properties are not decreased in a moist environment The powder mixed with distilled water forms a gel, which cures in a humid environment. The material starts setting after approximately 10 minutes and the final setting time is 15 minutes. It is not necessary to wait for the final setting to continue the treatment procedure. Indications – Treatment of perforations of root canal and furcation – Treatment of internal resorption – Retrograde root canal filling after apical resection – Pulp capping – Pulpotomy – Apical plug during apexification treatment FDA UDI
- Model / Reference
- 20190 FDA UDI
- Description
- PD MTA White is a radiopaque root canal repair material material. The material composed of several mineral oxides is made up of thin hydrophilic particles showing the following advantages : – Optimized particle size allowing homogeneous and complete wetting during mixing – Avoids bacterial migration and penetration of tissue fluids into the root canal thanks to its excellent marginal sealing capacity – No need to dry the treated site. PD MTA White properties are not decreased in a moist environment The powder mixed with distilled water forms a gel, which cures in a humid environment. The material starts setting after approximately 10 minutes and the final setting time is 15 minutes. It is not necessary to wait for the final setting to continue the treatment procedure. Indications – Treatment of perforations of root canal and furcation – Treatment of internal resorption – Retrograde root canal filling after apical resection – Pulp capping – Pulpotomy – Apical plug during apexification treatment FDA UDI
Identifiers
- Catalog Number
- 20190 FDA UDI
- Primary DI / UDI-DI
- 07640159160014 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
Yes
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
PD MTA White by Produits dentaires S.A. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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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
- Produits dentaires S.A.
Sources (1)
- FDA UDI 594861b6-54e9-41dc-8beb-de1fff552f93 36 fields · synced May 30, 2026