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FDA 510(k)

VISION ESTHETIC PORCELAIN SYSTEM

K-Number: K000680 · 2000-05-25

ApplicantMidatlantic Division of Dentrex, Inc.
Decision Date2000-05-25
Product CodeEIH
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

VISION ESTHETIC PORCELAIN SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Midatlantic Division of Dentrex, Inc.. It received FDA 510(k) clearance on 2000-05-25 under 510(k) number K000680. 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 VISION ESTHETIC PORCELAIN SYSTEM?

VISION ESTHETIC PORCELAIN SYSTEM is a medical device that received FDA 510(k) clearance on 2000-05-25. The listed applicant is Midatlantic Division of Dentrex, Inc.. The 510(k) number is K000680.

When did VISION ESTHETIC PORCELAIN SYSTEM receive FDA 510(k) clearance?

VISION ESTHETIC PORCELAIN SYSTEM received FDA 510(k) clearance on 2000-05-25, under 510(k) number K000680.

Who is the listed applicant for VISION ESTHETIC PORCELAIN SYSTEM?

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

What is the FDA product code for VISION ESTHETIC PORCELAIN SYSTEM?

The FDA product code for VISION ESTHETIC PORCELAIN SYSTEM is EIH.

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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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