Cleared Traditional

K231205 - GuruNanda Dry Mouth Oral Rinse and GuruNanda Dry Mouth Oral Spray (FDA 510(k) Clearance)

K231205 · Gurunanda, LLC · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Aug 2023
Decision
117d
Days
-
Risk

K231205 is an FDA 510(k) clearance for the GuruNanda Dry Mouth Oral Rinse and GuruNanda Dry Mouth Oral Spray. Classified as Saliva, Artificial (product code LFD).

Submitted by Gurunanda, LLC (Buena Park, US). The FDA issued a Cleared decision on August 22, 2023 after a review of 117 days - within the typical 510(k) review window.

This device falls under the Dental FDA review panel. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Dental review framework, consistent with the majority of Class II 510(k) submissions.

View all Gurunanda, LLC devices

Submission Details

510(k) Number K231205 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (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
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
10d faster than avg
Panel avg: 127d · This submission: 117d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code LFD Saliva, Artificial
Device Class -

Regulatory Peers - LFD Saliva, Artificial

All 49
Devices cleared under the same product code (LFD) and FDA review panel - the closest regulatory comparables to K231205.
Allday Moisturizing Rinse
K253778 · Elevate Oral Care · Feb 2026
CloSYS® Dry Mouth Sensitive Mouth Rinse
K250390 · Rowpar Pharmaceuticals, Inc. · May 2025
Salivea Dry Mouth Moisturizing Gel (Dry Mouth Moisturizing Gel)
K240508 · Laclede, Inc. · Apr 2024
Caphosol® Artifical Saliva (32 doses sachet box)
K234015 · Eusa Pharma (Uk) Limited · Mar 2024
Dentilube Spray
K202689 · Oxy2plus, LLC · Sep 2021
Oral-B Dry Mouth Oral Rinse
K203567 · The Procter & Gamble Company · Apr 2021