Cleared Traditional

K163029 - Hydris™ Oral Rinse (FDA 510(k) Clearance)

K163029 · Biopharm Consult, LLC · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jun 2017
Decision
231d
Days
-
Risk

K163029 is an FDA 510(k) clearance for the Hydris™ Oral Rinse. Classified as Saliva, Artificial (product code LFD).

Submitted by Biopharm Consult, LLC (Henrico, US). The FDA issued a Cleared decision on June 19, 2017 after a review of 231 days - an extended review cycle.

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 Biopharm Consult, LLC devices

Submission Details

510(k) Number K163029 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 31, 2016
Decision Date June 19, 2017
Days to Decision 231 days
Submission Type Traditional
Review Panel Dental (DE)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
104d slower than avg
Panel avg: 127d · This submission: 231d
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 K163029.
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
GuruNanda Dry Mouth Oral Rinse and GuruNanda Dry Mouth Oral Spray
K231205 · Gurunanda, LLC · Aug 2023
Dentilube Spray
K202689 · Oxy2plus, LLC · Sep 2021