LC ResinCal PC

FDA 510(k) K202413 · S&C Polymer Silicon- Und Composite Spezialitaten GmbH

Substantially Equivalent

510(k) numberK202413

Submission

Device name
LC ResinCal PC
Applicant
S&C Polymer Silicon- Und Composite Spezialitaten GmbH
Elmshorn, DE
Received
August 24, 2020
Decision date
November 20, 2020
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 ResinCal PC cleared by the FDA?

LC ResinCal PC (K202413) received a 510(k) decision of Substantially Equivalent on November 20, 2020, 88 days after the submission was received.

What is the product code of K202413?

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