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 |