The following data is part of a premarket notification filed by Angelus Industria De Productos Odontologicos Sa with the FDA for Mta Fillapex.
Device ID | K140247 |
510k Number | K140247 |
Device Name: | MTA FILLAPEX |
Classification | Resin, Root Canal Filling |
Applicant | ANGELUS INDUSTRIA DE PRODUCTOS ODONTOLOGICOS SA 18851 NE 29TH AVE 720 Aventura, FL 33180 |
Contact | Tara Conrad |
Correspondent | Tara Conrad ANGELUS INDUSTRIA DE PRODUCTOS ODONTOLOGICOS SA 18851 NE 29TH AVE 720 Aventura, FL 33180 |
Product Code | KIF |
CFR Regulation Number | 872.3820 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Special |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2014-01-30 |
Decision Date | 2014-04-25 |
Summary: | summary |