Surefil one Self-adhesive Composite Hybrid
K-Number: K192530 · 2020-01-23
ApplicantDentsply Sirona
Decision Date2020-01-23
Product CodeEMA
Advisory CommitteeDE
DecisionSubstantially Equivalent
Device Summary
Surefil one Self-adhesive Composite Hybrid is a medical device manufactured by Dentsply Sirona. It received FDA 510(k) clearance on 2020-01-23 under approval number K192530. The device is classified under product code EMA. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the Surefil one Self-adhesive Composite Hybrid?
Surefil one Self-adhesive Composite Hybrid is a medical device that received FDA 510(k) clearance on 2020-01-23. It is manufactured by Dentsply Sirona. The 510(k) number is K192530.
When was Surefil one Self-adhesive Composite Hybrid approved by the FDA?
Surefil one Self-adhesive Composite Hybrid received FDA 510(k) clearance on 2020-01-23, under approval number K192530.
What company makes Surefil one Self-adhesive Composite Hybrid?
Surefil one Self-adhesive Composite Hybrid is manufactured by Dentsply Sirona.
What is the FDA product code for Surefil one Self-adhesive Composite Hybrid?
The FDA product code for Surefil one Self-adhesive Composite Hybrid is EMA.
Related Clinical Trials
Other Devices by Dentsply Sirona
Related Devices (Code: EMA)
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.