Cleared Traditional

K162888 - Cercon (FDA 510(k) Clearance)

K162888 · Dentsply Sirona · Dental device

Feb 2017

Decision

130d

Days

Class 2

Risk

K162888 is an FDA 510(k) clearance for the Cercon. This device is classified as a Powder, Porcelain (Class II - Special Controls, product code EIH).

Submitted by Dentsply Sirona (York, US). The FDA issued a Cleared decision on February 24, 2017, 130 days after receiving the submission on October 17, 2016.

This device falls under the Dental FDA review panel. Regulated under 21 CFR 872.6660.

Submission Details

510(k) Number	K162888 FDA.gov
FDA Decision	Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received	October 17, 2016
Decision Date	February 24, 2017
Days to Decision	130 days
Submission Type	Traditional
Review Panel	Dental (DE)
Summary	Summary PDF