LC Calciumhydroxide Liner

FDA 510(k) K141047 · S&C Polymer Silicon- Und Composite Spezialitaeten

Substantially Equivalent

510(k) numberK141047

Submission

Device name
LC Calciumhydroxide Liner
Applicant
S&C Polymer Silicon- Und Composite Spezialitaeten
Elmshorn, Schleswig-Holstein, DE
Received
April 23, 2014
Decision date
April 14, 2015
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) summary available from FDA

Official FDA 510(k) record

Device classification

Product code
EJK – Liner, Cavity, Calcium Hydroxide
Device class
Class II (moderate risk)
Regulation
21 CFR 872.3250
Specialty
Dental

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Questions and answers

When was LC Calciumhydroxide Liner cleared by the FDA?

LC Calciumhydroxide Liner (K141047) received a 510(k) decision of Substantially Equivalent on April 14, 2015, 356 days after the submission was received.

What is the product code of K141047?

The FDA product code is EJK – Liner, Cavity, Calcium Hydroxide, a Class II (moderate risk) device regulated under 21 CFR 872.3250.