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 |