L1P-1F (TRIOS 5)

Laser, Fluorescence Caries Detection

3Shape TRIOS A/S

The following data is part of a premarket notification filed by 3shape Trios A/s with the FDA for L1p-1f (trios 5).

Pre-market Notification Details

Device IDK221249
510k NumberK221249
Device Name:L1P-1F (TRIOS 5)
ClassificationLaser, Fluorescence Caries Detection
Applicant 3Shape TRIOS A/S Holmens Kanal 7 Copenhagen K,  DK Dk-1060
ContactKlaus Rudbaek Hoj
CorrespondentKlaus Rudbaek Hoj
3Shape TRIOS A/S Holmens Kanal 7 Copenhagen K,  DK Dk-1060
Product CodeNBL  
CFR Regulation Number872.1745 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2022-05-02
Decision Date2022-09-16

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