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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 the device name listed in this FDA 510(k) record. The listed applicant is Juvora, Ltd.. It received FDA 510(k) clearance on 2018-12-21 under 510(k) 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. The listed applicant is Juvora, Ltd.. The 510(k) number is K181331.

When did JUVORA Oyster White Dental Disc, CERAMILL PEEK by JUVORA, Oyster White receive FDA 510(k) clearance?

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

Who is the listed applicant for JUVORA Oyster White Dental Disc, CERAMILL PEEK by JUVORA, Oyster White?

The FDA 510(k) record lists Juvora, Ltd. as the applicant. This does not by itself establish the device manufacturer.

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.

Other records listing Juvora, Ltd. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K160918JUVORA Dental Disc, Ceramill PEEK by JUVORA

Related Devices (Code: EBI)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K261626UltraPrint Flexible Denture UVGuangzhou Heygears IMC., Inc.K262681NanoCeram Resin3BFAB TEKNOLOJI A.S.K262300Denture Base Resin V2Formlabs Ohio, Inc.K261474DENTCA Tru FlexibleDentca, Inc.K260569DB 4000 High Impact Denture BaseCarbon, Inc.K260376Denture BaseShandong Huge Dental Material Corporation

Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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