CEREC Guides
K-Number: K190059 · 2019-09-27
ApplicantDentsply Sirona
Decision Date2019-09-27
Product CodeNDP
Advisory CommitteeDE
DecisionSubstantially Equivalent
Device Summary
CEREC Guides is a medical device manufactured by Dentsply Sirona. It received FDA 510(k) clearance on 2019-09-27 under approval number K190059. The device is classified under product code NDP. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the CEREC Guides?
CEREC Guides is a medical device that received FDA 510(k) clearance on 2019-09-27. It is manufactured by Dentsply Sirona. The 510(k) number is K190059.
When was CEREC Guides approved by the FDA?
CEREC Guides received FDA 510(k) clearance on 2019-09-27, under approval number K190059.
What company makes CEREC Guides?
CEREC Guides is manufactured by Dentsply Sirona.
What is the FDA product code for CEREC Guides?
The FDA product code for CEREC Guides is NDP.
Other Devices by Dentsply Sirona
Related Devices (Code: NDP)
Official Source
View on FDA Database →Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.