Cleared Traditional

G•U•M HYDRAL Dry Mouth Oral Gel, G•U•M HYDRAL Dry Mouth Oral Rinse, G•U•M HYDRAL Dry Mouth Oral Spray (K181134) - FDA 510(k) Clearance

K181134 · Sunstar Americas, Inc. · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jul 2018
Decision
74d
Days
-
Risk

K181134 is an FDA 510(k) clearance for the G•U•M HYDRAL Dry Mouth Oral Gel, G•U•M HYDRAL Dry Mouth Oral Rinse, G•U•M HYD.... Classified as Saliva, Artificial (product code LFD).

Submitted by Sunstar Americas, Inc. (Schaumburg, US). The FDA issued a Cleared decision on July 13, 2018 after a review of 74 days - a notably fast clearance 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Sunstar Americas, Inc. devices

Submission Details

510(k) Number K181134 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 30, 2018
Decision Date July 13, 2018
Days to Decision 74 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
53d faster than avg
Panel avg: 127d · This submission: 74d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code LFD Saliva, Artificial
Device Class -

Regulatory Peers - LFD Saliva, Artificial

All 16
Devices cleared under the same product code (LFD) and FDA review panel - the closest regulatory comparables to K181134.
SmartMouth DryMouth Oral Rinse
K181194 · Triumph Pharmaceuticals, Inc. · Feb 2019
Salivea Dry Mouth Mouthwash, Salivea Dry Mouth Mouthspray
K180680 · Laclede, Inc. · Oct 2018
Voutia™
K173808 · Jeffrey Ward Cash, Dds · Jul 2018
Moisyn Dry Mouth Oral Rinse, Moisyn Dry Mouth Oral Mist, Moisyn Free Dry Mouth Oral Rinse, Moisyn Free Dry Mouth Oral Mist
K173237 · Syendgen, Inc. · Mar 2018
TheraBreath Dry Mouth Oral Rinse, TheraBreath Dry Mouth Lozenges
K171542 · Dr. Harold Katz, LLC (Dba Therabreath · Mar 2018
GC ORAL MOISTURIZING GEL
K101346 · GC America, Inc. · Jan 2011