FDA 510(k)

Prodigio Stain Powder

K-Number: K171167 · 2017-12-13

Decision Date2017-12-13

Product CodeEIH

Advisory CommitteeDE

DecisionSubstantially Equivalent

Device Summary

Prodigio Stain Powder is the device name listed in this FDA 510(k) record. The listed applicant is Operart, LLC. It received FDA 510(k) clearance on 2017-12-13 under 510(k) number K171167. 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 Prodigio Stain Powder?

Prodigio Stain Powder is a medical device that received FDA 510(k) clearance on 2017-12-13. The listed applicant is Operart, LLC. The 510(k) number is K171167.

When did Prodigio Stain Powder receive FDA 510(k) clearance?

Prodigio Stain Powder received FDA 510(k) clearance on 2017-12-13, under 510(k) number K171167.

Who is the listed applicant for Prodigio Stain Powder?

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

What is the FDA product code for Prodigio Stain Powder?

The FDA product code for Prodigio Stain Powder 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 Dandy K260918Zolid LunarisAmann Girrbach AG K260859Rosetta SM, Rosetta SPHass Corp.K253191DCMhotbond zirconDental Creativ Management GmbH

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.