HCG Zirconia Ceramic Block

Powder, Porcelain

Hocheng Corporation

The following data is part of a premarket notification filed by Hocheng Corporation with the FDA for Hcg Zirconia Ceramic Block.

Pre-market Notification Details

Device IDK193090
510k NumberK193090
Device Name:HCG Zirconia Ceramic Block
ClassificationPowder, Porcelain
Applicant Hocheng Corporation 1F.,No.398, Xingshan Rd., Neihu Dist. Taipei City,  TW 11469
ContactChieh-ju Huang
CorrespondentChieh-ju Huang
Hocheng Corporation 1F.,No.398, Xingshan Rd., Neihu Dist. Taipei City,  TW 11469
Product CodeEIH  
CFR Regulation Number872.6660 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2019-11-06
Decision Date2020-10-29

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