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FDA 510(k)

Pavati Z40.2 Zirconia

K-Number: K160867 · 2016-09-12

ApplicantCcri, Inc.
Decision Date2016-09-12
Product CodeEIH
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

Pavati Z40.2 Zirconia is the device name listed in this FDA 510(k) record. The listed applicant is Ccri, Inc.. It received FDA 510(k) clearance on 2016-09-12 under 510(k) number K160867. The device is classified under product code EIH. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Pavati Z40.2 Zirconia?

Pavati Z40.2 Zirconia is a medical device that received FDA 510(k) clearance on 2016-09-12. The listed applicant is Ccri, Inc.. The 510(k) number is K160867.

When did Pavati Z40.2 Zirconia receive FDA 510(k) clearance?

Pavati Z40.2 Zirconia received FDA 510(k) clearance on 2016-09-12, under 510(k) number K160867.

Who is the listed applicant for Pavati Z40.2 Zirconia?

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

What is the FDA product code for Pavati Z40.2 Zirconia?

The FDA product code for Pavati Z40.2 Zirconia is EIH.

Related Devices (Code: EIH)

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.

K262239Obsidian® Press Over ZirconiaPrismatik Dentalcraft, Inc.K261046Dental Zirconia Blank & Coloring LiquidHunan Qinghao Puzhong Technology Co., Ltd.K262195Dandy Ceramic Stain and GlazeZima International Inc., dba DandyK260918Zolid LunarisAmann Girrbach AGK260859Rosetta SM, Rosetta SPHass Corp.K253191DCMhotbond zirconDental Creativ Management GmbH

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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