Dentsply Sirona Universal Spray Glazes
K-Number: K202629 · 2021-01-20
ApplicantDentsply Sirona
Decision Date2021-01-20
Product CodeEIH
Advisory CommitteeDE
DecisionSubstantially Equivalent
Device Summary
Dentsply Sirona Universal Spray Glazes is a medical device manufactured by Dentsply Sirona. It received FDA 510(k) clearance on 2021-01-20 under approval number K202629. The device is classified under product code EIH. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the Dentsply Sirona Universal Spray Glazes?
Dentsply Sirona Universal Spray Glazes is a medical device that received FDA 510(k) clearance on 2021-01-20. It is manufactured by Dentsply Sirona. The 510(k) number is K202629.
When was Dentsply Sirona Universal Spray Glazes approved by the FDA?
Dentsply Sirona Universal Spray Glazes received FDA 510(k) clearance on 2021-01-20, under approval number K202629.
What company makes Dentsply Sirona Universal Spray Glazes?
Dentsply Sirona Universal Spray Glazes is manufactured by Dentsply Sirona.
What is the FDA product code for Dentsply Sirona Universal Spray Glazes?
The FDA product code for Dentsply Sirona Universal Spray Glazes is EIH.
Other Devices by Dentsply Sirona
Related Devices (Code: EIH)
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.