Halley resin system
K-Number: K191427 · 2019-08-26
ApplicantDentsply Sirona
Decision Date2019-08-26
Product CodeEBI
Advisory CommitteeDE
DecisionSubstantially Equivalent
Device Summary
Halley resin system is a medical device manufactured by Dentsply Sirona. It received FDA 510(k) clearance on 2019-08-26 under approval number K191427. 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 system?
Halley resin system is a medical device that received FDA 510(k) clearance on 2019-08-26. It is manufactured by Dentsply Sirona. The 510(k) number is K191427.
When was Halley resin system approved by the FDA?
Halley resin system received FDA 510(k) clearance on 2019-08-26, under approval number K191427.
What company makes Halley resin system?
Halley resin system is manufactured by Dentsply Sirona.
What is the FDA product code for Halley resin system?
The FDA product code for Halley resin system 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.