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FDA 510(k)

CRYSTAR PORCELAIN

K-Number: K833643 · 1983-12-29

ApplicantShofu Dental Corp.
Decision Date1983-12-29
Product CodeEIH
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

CRYSTAR PORCELAIN is the device name listed in this FDA 510(k) record. The listed applicant is Shofu Dental Corp.. It received FDA 510(k) clearance on 1983-12-29 under 510(k) number K833643. 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 CRYSTAR PORCELAIN?

CRYSTAR PORCELAIN is a medical device that received FDA 510(k) clearance on 1983-12-29. The listed applicant is Shofu Dental Corp.. The 510(k) number is K833643.

When did CRYSTAR PORCELAIN receive FDA 510(k) clearance?

CRYSTAR PORCELAIN received FDA 510(k) clearance on 1983-12-29, under 510(k) number K833643.

Who is the listed applicant for CRYSTAR PORCELAIN?

The FDA 510(k) record lists Shofu Dental Corp. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for CRYSTAR PORCELAIN?

The FDA product code for CRYSTAR PORCELAIN is EIH.

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Other records listing Shofu Dental Corp. 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.

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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

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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