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

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
05902729753784 K221249 000
05902729753777 K221249 000
05902729753760 K221249 000
05902729753739 K221249 000
05902729753722 K221249 000
05902729753685 K221249 000
05902729753678 K221249 000
05902729753746 K221249 000
05902729754149 K221249 000

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