DEPENDABOND

Adhesive, Bracket And Tooth Conditioner, Resin

ORTHO SOURCE

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

Pre-market Notification Details

Device IDK860959
510k NumberK860959
Device Name:DEPENDABOND
ClassificationAdhesive, Bracket And Tooth Conditioner, Resin
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 CodeDYH  
CFR Regulation Number872.3750 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1986-03-13
Decision Date1986-03-25

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
D9115578610 K860959 000
D9115578460 K860959 000
D9115574420 K860959 000

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