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FDA 510(k)

JUVORA Oyster White Dental Disc, CERAMILL PEEK by JUVORA, Oyster White

K-Number: K181331 · 2018-12-21

ApplicantJuvora, Ltd.
Decision Date2018-12-21
Product CodeEBI
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

JUVORA Oyster White Dental Disc, CERAMILL PEEK by JUVORA, Oyster White is a medical device manufactured by Juvora, Ltd.. It received FDA 510(k) clearance on 2018-12-21 under approval number K181331. 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 Oyster White Dental Disc, CERAMILL PEEK by JUVORA, Oyster White?

JUVORA Oyster White Dental Disc, CERAMILL PEEK by JUVORA, Oyster White is a medical device that received FDA 510(k) clearance on 2018-12-21. It is manufactured by Juvora, Ltd.. The 510(k) number is K181331.

When was JUVORA Oyster White Dental Disc, CERAMILL PEEK by JUVORA, Oyster White approved by the FDA?

JUVORA Oyster White Dental Disc, CERAMILL PEEK by JUVORA, Oyster White received FDA 510(k) clearance on 2018-12-21, under approval number K181331.

What company makes JUVORA Oyster White Dental Disc, CERAMILL PEEK by JUVORA, Oyster White?

JUVORA Oyster White Dental Disc, CERAMILL PEEK by JUVORA, Oyster White is manufactured by Juvora, Ltd..

What is the FDA product code for JUVORA Oyster White Dental Disc, CERAMILL PEEK by JUVORA, Oyster White?

The FDA product code for JUVORA Oyster White Dental Disc, CERAMILL PEEK by JUVORA, Oyster White 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.

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