The following data is part of a premarket notification filed by Angelus Industria De Productos Odontologicos with the FDA for Mta Repair Hp.
| Device ID | K151047 |
| 510k Number | K151047 |
| Device Name: | MTA Repair HP |
| Classification | Resin, Root Canal Filling |
| Applicant | ANGELUS INDUSTRIA DE PRODUCTOS ODONTOLOGICOS RUA WALDIR LANDGRAF, 101 Londrina, Pr, BR 86031-218 |
| Contact | Paulo Sergio Calixto De Oliveria |
| Correspondent | Lilian Llull TECHLINK INTERNATIONAL PO BOX 694125 Miami, FL 33160 |
| Product Code | KIF |
| CFR Regulation Number | 872.3820 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2015-04-20 |
| Decision Date | 2016-08-31 |
| Summary: | summary |