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510(k) K202689

Dentilube Spray by Oxy2plus, LLC — Product Code LFD

K202689 is an FDA 510(k) premarket notification submitted by Oxy2plus, LLC for the device "Dentilube Spray". The FDA issued a decision of Substantially Equivalent on September 3, 2021. The device falls under product code LFD (Saliva, Artificial), a Class U device.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 3, 2021
Date Received
September 15, 2020
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Saliva, Artificial
Device Class
Class U
Regulation Number
Review Panel
DE
Submission Type

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FDA data resources