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FDA 510(k)

ANTAGON PORCELAIN

K-Number: K982129 · 1998-08-04

ApplicantEuropean Dental Imports, Inc.
Decision Date1998-08-04
Product CodeEIH
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

ANTAGON PORCELAIN is the device name listed in this FDA 510(k) record. The listed applicant is European Dental Imports, Inc.. It received FDA 510(k) clearance on 1998-08-04 under 510(k) number K982129. 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 ANTAGON PORCELAIN?

ANTAGON PORCELAIN is a medical device that received FDA 510(k) clearance on 1998-08-04. The listed applicant is European Dental Imports, Inc.. The 510(k) number is K982129.

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

ANTAGON PORCELAIN received FDA 510(k) clearance on 1998-08-04, under 510(k) number K982129.

Who is the listed applicant for ANTAGON PORCELAIN?

The FDA 510(k) record lists European Dental Imports, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for ANTAGON PORCELAIN?

The FDA product code for ANTAGON PORCELAIN is EIH.

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Other records listing European Dental Imports, Inc. 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.

K981001ORION VESTA DENTAL ALLOYK981002ORION WX DENTAL ALLOYK981000CARRARA PORCELAIN AND CARRARA VINCENT PORCELAINK980661CERA E DENTAL ALLOYK980660BIOGOLD PLUS DENTAL ALLOYK980597CARRARA PDF, CARRARA H, CARRARA R

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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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