JUVORA Dental Disc, Ceramill PEEK by JUVORA
K-Number: K160918 · 2017-02-13
ApplicantJuvora
Decision Date2017-02-13
Product CodeEBI
Advisory CommitteeDE
DecisionSubstantially Equivalent
Device Summary
JUVORA Dental Disc, Ceramill PEEK by JUVORA is a medical device manufactured by Juvora. It received FDA 510(k) clearance on 2017-02-13 under approval number K160918. 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 JUVORA Dental Disc, Ceramill PEEK by JUVORA?
JUVORA Dental Disc, Ceramill PEEK by JUVORA is a medical device that received FDA 510(k) clearance on 2017-02-13. It is manufactured by Juvora. The 510(k) number is K160918.
When was JUVORA Dental Disc, Ceramill PEEK by JUVORA approved by the FDA?
JUVORA Dental Disc, Ceramill PEEK by JUVORA received FDA 510(k) clearance on 2017-02-13, under approval number K160918.
What company makes JUVORA Dental Disc, Ceramill PEEK by JUVORA?
JUVORA Dental Disc, Ceramill PEEK by JUVORA is manufactured by Juvora.
What is the FDA product code for JUVORA Dental Disc, Ceramill PEEK by JUVORA?
The FDA product code for JUVORA Dental Disc, Ceramill PEEK by JUVORA 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.