Cleared Traditional

GuruNanda Dry Mouth Oral Rinse and GuruNanda Dry Mouth Oral Spray

K231205 · Gurunanda, LLC · Dental

Aug 2023

Decision

117d

Days

—

Risk

About This 510(k) Submission

K231205 is an FDA 510(k) clearance for the GuruNanda Dry Mouth Oral Rinse and GuruNanda Dry Mouth Oral Spray, a Saliva, Artificial, submitted by Gurunanda, LLC (Buena Park, US). The FDA issued a Cleared decision on August 22, 2023, 117 days after receiving the submission on April 27, 2023. This device falls under the Dental review panel.

Submission Details

510(k) Number	K231205 FDA.gov
FDA Decision	Cleared SESE
Date Received	April 27, 2023
Decision Date	August 22, 2023
Days to Decision	117 days
Submission Type	Traditional
Review Panel	Dental (DE)
Summary	Summary PDF