Cleared Traditional

Dentilube Spray

K202689 · Oxy2plus, LLC · Dental

Sep 2021

Decision

353d

Days

—

Risk

About This 510(k) Submission

K202689 is an FDA 510(k) clearance for the Dentilube Spray, 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 review panel.

Submission Details

510(k) Number	K202689 FDA.gov
FDA Decision	Cleared 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