Halley resin
K-Number: K190043 · 2019-04-24
ApplicantDentsply Sirona
Decision Date2019-04-24
Product CodeEBI
Advisory CommitteeDE
DecisionSubstantially Equivalent
Device Summary
Halley resin is a medical device manufactured by Dentsply Sirona. It received FDA 510(k) clearance on 2019-04-24 under approval number K190043. The device is classified under product code EBI. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the Halley resin?
Halley resin is a medical device that received FDA 510(k) clearance on 2019-04-24. It is manufactured by Dentsply Sirona. The 510(k) number is K190043.
When was Halley resin approved by the FDA?
Halley resin received FDA 510(k) clearance on 2019-04-24, under approval number K190043.
What company makes Halley resin?
Halley resin is manufactured by Dentsply Sirona.
What is the FDA product code for Halley resin?
The FDA product code for Halley resin is EBI.
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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.