Dentilube Spray

Saliva, Artificial

Oxy2plus, LLC

The following data is part of a premarket notification filed by Oxy2plus, Llc with the FDA for Dentilube Spray.

Pre-market Notification Details

Device IDK202689
510k NumberK202689
Device Name:Dentilube Spray
ClassificationSaliva, Artificial
Applicant Oxy2plus, LLC 4120 Rosemead Blvd Rosemead,  CA  91770
ContactChun Nan Lin
CorrespondentChun Nan Lin
Oxy2plus, LLC 4120 Rosemead Blvd Rosemead,  CA  91770
Product CodeLFD  
CFR Regulation Number510(k) Premarket Notification [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2020-09-15
Decision Date2021-09-03

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