The following data is part of a premarket notification filed by S&c Polymer Silicon- Und Composite Spezialitaeten with the FDA for Lc Calciumhydroxide Liner.
| Device ID | K141047 |
| 510k Number | K141047 |
| Device Name: | LC CALCIUMHYDROXIDE LINER |
| Classification | Liner, Cavity, Calcium Hydroxide |
| 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 | EJK |
| CFR Regulation Number | 872.3250 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2014-04-23 |
| Decision Date | 2015-04-14 |
| Summary: | summary |