AA Temp Temporary Restoration 3D Printing Photoreactive Resin

Crown And Bridge, Temporary, Resin

Enlighten Materials Co., Ltd

The following data is part of a premarket notification filed by Enlighten Materials Co., Ltd with the FDA for Aa Temp Temporary Restoration 3d Printing Photoreactive Resin.

Pre-market Notification Details

Device IDK191590
510k NumberK191590
Device Name:AA Temp Temporary Restoration 3D Printing Photoreactive Resin
ClassificationCrown And Bridge, Temporary, Resin
Applicant Enlighten Materials Co., Ltd 8F., NO.138, Sec.2, Jinshan S. Rd., Da-an Dist Taipei,  TW 10642
ContactJiun Ming Su
CorrespondentChih-hao Kao
Voler Biotech Consulting Co., Ltd. No. 3-1, Ln 58, Hejiang St., Zhongshan Dist., Taipei City,  TW 10480
Product CodeEBG  
CFR Regulation Number872.3770 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2019-06-14
Decision Date2020-05-05

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