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FDA 510(k)

NOVA CERAMIC SPRAY GLAZE AND TRU-PAQUE, OPAQUE PORCELAIN

K-Number: K030859 · 2003-03-27

ApplicantEnamelite, LLC
Decision Date2003-03-27
Product CodeEIH
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

NOVA CERAMIC SPRAY GLAZE AND TRU-PAQUE, OPAQUE PORCELAIN is the device name listed in this FDA 510(k) record. The listed applicant is Enamelite, LLC. It received FDA 510(k) clearance on 2003-03-27 under 510(k) number K030859. 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 NOVA CERAMIC SPRAY GLAZE AND TRU-PAQUE, OPAQUE PORCELAIN?

NOVA CERAMIC SPRAY GLAZE AND TRU-PAQUE, OPAQUE PORCELAIN is a medical device that received FDA 510(k) clearance on 2003-03-27. The listed applicant is Enamelite, LLC. The 510(k) number is K030859.

When did NOVA CERAMIC SPRAY GLAZE AND TRU-PAQUE, OPAQUE PORCELAIN receive FDA 510(k) clearance?

NOVA CERAMIC SPRAY GLAZE AND TRU-PAQUE, OPAQUE PORCELAIN received FDA 510(k) clearance on 2003-03-27, under 510(k) number K030859.

Who is the listed applicant for NOVA CERAMIC SPRAY GLAZE AND TRU-PAQUE, OPAQUE PORCELAIN?

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

What is the FDA product code for NOVA CERAMIC SPRAY GLAZE AND TRU-PAQUE, OPAQUE PORCELAIN?

The FDA product code for NOVA CERAMIC SPRAY GLAZE AND TRU-PAQUE, OPAQUE PORCELAIN is EIH.

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Other records listing Enamelite, LLC 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.

K093019ENAMELITE ACRYSEAL SPRAY SEALANT

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.

K262074Any-ZircosMediclus Co., Ltd.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.

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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