MTA-FILLAPEX
Resin, Root Canal Filling
PAXMED INTERNATIONAL
The following data is part of a premarket notification filed by Paxmed International with the FDA for Mta-fillapex.
Pre-market Notification Details
| Device ID | K113568 |
| 510k Number | K113568 |
| Device Name: | MTA-FILLAPEX |
| Classification | Resin, Root Canal Filling |
| Applicant | PAXMED INTERNATIONAL 11234 EL CAMINO SUITE 200 San Diego, CA 92130 |
| Contact | Allison Komiyama |
| Correspondent | Allison Komiyama PAXMED INTERNATIONAL 11234 EL CAMINO SUITE 200 San Diego, CA 92130 |
| Product Code | KIF |
| CFR Regulation Number | 872.3820 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2011-12-02 |
| Decision Date | 2012-08-21 |
| Summary: | summary |
NIH GUDID Devices
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00850002458596 | K113568 | 000 |
| TQ26126092991 | K113568 | 000 |
Trademark Results [MTA-FILLAPEX]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 MTA-FILLAPEX 85267434 4500133 Live/Registered |
Angelus Industria de Produtos Odontologicos S/A 2011-03-15 |
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