510(k) Report

Devices descending from K090169

6 later devices reach Spectra Fluorescence Caries Detection Device through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K150672VistaCam iX ProofDurr Dental AG20165—
+2K221249L1P-1F (Trios 5)3Shape TRIOS A/S20221—
+2K183471IC-WHCD100 (Inspire)Good Doctors Co., Ltd.20200—
+2K171007Fluorescence ModeCarl Zeiss Suzhou Co., Ltd.20181—
+3K252464Surgical Microscope (OMS2360, OMS2380)Zumax Medical Co., Ltd.20260—
+3K242103TRIOS Ready Tip3Shape TRIOS A/S20250—