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FDA 510(k)

DEN-MAT CERINATE PORCELAIN

K-Number: K895731 · 1990-08-03

ApplicantDen-Mat Corp.
Decision Date1990-08-03
Product CodeEIH
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

DEN-MAT CERINATE PORCELAIN is the device name listed in this FDA 510(k) record. The listed applicant is Den-Mat Corp.. It received FDA 510(k) clearance on 1990-08-03 under 510(k) number K895731. 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 DEN-MAT CERINATE PORCELAIN?

DEN-MAT CERINATE PORCELAIN is a medical device that received FDA 510(k) clearance on 1990-08-03. The listed applicant is Den-Mat Corp.. The 510(k) number is K895731.

When did DEN-MAT CERINATE PORCELAIN receive FDA 510(k) clearance?

DEN-MAT CERINATE PORCELAIN received FDA 510(k) clearance on 1990-08-03, under 510(k) number K895731.

Who is the listed applicant for DEN-MAT CERINATE PORCELAIN?

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

What is the FDA product code for DEN-MAT CERINATE PORCELAIN?

The FDA product code for DEN-MAT CERINATE PORCELAIN is EIH.

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Other records listing Den-Mat 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.

K9831061ST IMPRESSIONK895269DEN-MAT LAMI-QUICKK881918LIGHT-CURED ZIONOMER CEMENTK875351DEN-MAT PORETCH (PORCELAIN ETCHANT)K872510DEN-MAT TENUREK870130DEN-MAT SECURE ANTI-ROTATIONAL POST-CORE SYSTEM

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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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