Perfit FS Dental Zirconia Fully Sintered Block

Powder, Porcelain

Vatech Acucera, Inc.

The following data is part of a premarket notification filed by Vatech Acucera, Inc. with the FDA for Perfit Fs Dental Zirconia Fully Sintered Block.

Pre-market Notification Details

Device IDK203590
510k NumberK203590
Device Name:Perfit FS Dental Zirconia Fully Sintered Block
ClassificationPowder, Porcelain
Applicant Vatech Acucera, Inc. 2544, Nambuk-daero, Idong-eup, Cheoin-gu Yongin-si,  KR 17138
ContactKyung Wook Kwon
CorrespondentKyung Wook Kwon
Vatech Acucera, Inc. 2544, Nambuk-daero, Idong-eup, Cheoin-gu Yongin-si,  KR 17138
Product CodeEIH  
CFR Regulation Number872.6660 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2020-12-08
Decision Date2021-06-24

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