The following data is part of a premarket notification filed by S&c Polymer Silicon- Und Composite Spezialitaeten with the FDA for Mta Cements.
| Device ID | K130125 |
| 510k Number | K130125 |
| Device Name: | MTA CEMENTS |
| Classification | Resin, Root Canal Filling |
| Applicant | S&C POLYMER SILICON- UND COMPOSITE SPEZIALITAETEN ROBERT-BOSCH-STRASSE 2 Elmshorn, Schleswig-holstein, DE 25335 |
| Contact | Christian Boettcher |
| Correspondent | Christian Boettcher S&C POLYMER SILICON- UND COMPOSITE SPEZIALITAETEN ROBERT-BOSCH-STRASSE 2 Elmshorn, Schleswig-holstein, DE 25335 |
| Product Code | KIF |
| CFR Regulation Number | 872.3820 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2013-01-17 |
| Decision Date | 2013-07-24 |