BeautiBond Universal

Agent, Tooth Bonding, Resin

Shofu Dental Corporation

The following data is part of a premarket notification filed by Shofu Dental Corporation with the FDA for Beautibond Universal.

Pre-market Notification Details

Device IDK180803
510k NumberK180803
Device Name:BeautiBond Universal
ClassificationAgent, Tooth Bonding, Resin
Applicant Shofu Dental Corporation 1225 Stone Drive San Marcos,  CA  92078
ContactMauro Malzyner
CorrespondentMauro Malzyner
Shofu Dental Corporation 1225 Stone Drive San Marcos,  CA  92078
Product CodeKLE  
CFR Regulation Number872.3200 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2018-03-28
Decision Date2018-09-26

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