The following data is part of a premarket notification filed by Angelus Industria De Productos Odontologicos with the FDA for Mta Angelus.
| Device ID | K112046 |
| 510k Number | K112046 |
| Device Name: | MTA ANGELUS |
| Classification | Resin, Root Canal Filling |
| Applicant | ANGELUS INDUSTRIA DE PRODUCTOS ODONTOLOGICOS 11234 EL CAMINO REAL, SUITE 200 San Diego, CA 92130 |
| Contact | Linda K Schulz |
| Correspondent | Linda K Schulz ANGELUS INDUSTRIA DE PRODUCTOS ODONTOLOGICOS 11234 EL CAMINO REAL, 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 | 2011-07-18 |
| Decision Date | 2012-01-06 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00366975013149 | K112046 | 000 |
| 00366975013132 | K112046 | 000 |
| 10304040016845 | K112046 | 000 |
| 10304040016821 | K112046 | 000 |
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
![]() MTA ANGELUS 87120937 not registered Dead/Abandoned |
ANGELUS INDÃSTRIA DE PRODUTOS ODONTOLÃGICOS S/A. 2016-07-29 |