Cercon

Powder, Porcelain

Dentsply Sirona

The following data is part of a premarket notification filed by Dentsply Sirona with the FDA for Cercon.

Pre-market Notification Details

• Device ID: K162888
• 510k Number: K162888
• Device Name: Cercon
• Classification: Powder, Porcelain
• Applicant: Dentsply Sirona 221 West Philadelphia Street Suite 60 York, PA 17404
• Contact: Karl Nittinger
• Correspondent: Karl Nittinger; Dentsply Sirona 221 West Philadelphia Street Suite 60 York, PA 17404
• Product Code: EIH
• CFR Regulation Number: 872.6660 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2016-10-17
• Decision Date: 2017-02-24
• Summary: summary