Cleared Traditional

K202689 - Dentilube Spray (FDA 510(k) Clearance)

K202689 · Oxy2plus, LLC · Dental device
Sep 2021
Decision
353d
Days
-
Risk

K202689 is an FDA 510(k) clearance for the Dentilube Spray. This device is classified as a Saliva, Artificial.

Submitted by Oxy2plus, LLC (Rosemead, US). The FDA issued a Cleared decision on September 3, 2021, 353 days after receiving the submission on September 15, 2020.

This device falls under the Dental FDA review panel.

Submission Details

510(k) Number K202689 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 15, 2020
Decision Date September 03, 2021
Days to Decision 353 days
Submission Type Traditional
Review Panel Dental (DE)
Summary Summary PDF

Device Classification

Product Code LFD - Saliva, Artificial
Device Class -