Cerec Blocs C in

FDA 510(k) K123952 · Sirona Dental Systems GmbH

Substantially Equivalent

510(k) numberK123952

Submission

Device name
Cerec Blocs C in
Applicant
Sirona Dental Systems GmbH
Bensheim, DE
Received
December 21, 2012
Decision date
March 20, 2013
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) summary available from FDA

Official FDA 510(k) record

Device classification

Product code
EIH – Powder, Porcelain
Device class
Class II (moderate risk)
Regulation
21 CFR 872.6660
Specialty
Dental

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Questions and answers

When was Cerec Blocs C in cleared by the FDA?

Cerec Blocs C in (K123952) received a 510(k) decision of Substantially Equivalent on March 20, 2013, 89 days after the submission was received.

What is the product code of K123952?

The FDA product code is EIH – Powder, Porcelain, a Class II (moderate risk) device regulated under 21 CFR 872.6660.