510(k) K141047

LC CALCIUMHYDROXIDE LINER by S&C Polymer Silicon- Und Composite Spezialitaeten — Product Code EJK

K141047 is an FDA 510(k) premarket notification submitted by S&C Polymer Silicon- Und Composite Spezialitaeten for the device "LC CALCIUMHYDROXIDE LINER". The FDA issued a decision of Substantially Equivalent on April 14, 2015. The device falls under product code EJK (Liner, Cavity, Calcium Hydroxide), a Class II device regulated under 21 CFR 872.3250. S&C Polymer Silicon- Und Composite Spezialitaeten has at least 3 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 14, 2015
Date Received
April 23, 2014
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Liner, Cavity, Calcium Hydroxide
Device Class
Class II
Regulation Number
872.3250
Review Panel
DE
Submission Type