ORTHOSOURCE ETCH SYSTEMS

Sealant, Pit And Fissure, And Conditioner

ORTHO SOURCE

The following data is part of a premarket notification filed by Ortho Source with the FDA for Orthosource Etch Systems.

Pre-market Notification Details

Device IDK861245
510k NumberK861245
Device Name:ORTHOSOURCE ETCH SYSTEMS
ClassificationSealant, Pit And Fissure, And Conditioner
Applicant ORTHO SOURCE 12021 RIVERSIDE DR. SUITE 201 North Hollywood,  CA  91607
ContactLloyd R Taylor
CorrespondentLloyd R Taylor
ORTHO SOURCE 12021 RIVERSIDE DR. SUITE 201 North Hollywood,  CA  91607
Product CodeEBC  
CFR Regulation Number872.3765 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1986-04-02
Decision Date1986-04-11

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
D9115574670 K861245 000
D911557424K1 K861245 000
D911557422K1 K861245 000
D9115574190 K861245 000
D9115574180 K861245 000
D9115574150 K861245 000
D911557618C251 K861245 000
D911557617C251 K861245 000
D911557418C251 K861245 000
D911557466601 K861245 000
D911557468601 K861245 000
D911557041503 K861245 000
D911557040503 K861245 000
D9115576190 K861245 000
D9115576180 K861245 000
D9115576170 K861245 000
D9115576150 K861245 000
D9115575190 K861245 000
D9115575150 K861245 000
D9115574120 K861245 000

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.