LFD

FDA Product Code LFD: Saliva, Artificial

Leading manufacturers include Laclede, Inc., The Procter & Gamble Company and Rowpar Pharmaceuticals, Inc..

50
Total
50
Cleared
182d
Avg days
1981
Since
Declining activity - 2 submissions in the last 2 years vs 3 in the prior period
Review times improving: avg 95d recently vs 185d historically

FDA 510(k) Cleared Saliva, Artificial Devices (Product Code LFD)

50 devices
1–24 of 50
Cleared Feb 27, 2026
Allday Moisturizing Rinse
K253778
Elevate Oral Care
Dental · 93d
Cleared May 19, 2025
CloSYS® Dry Mouth Sensitive Mouth Rinse
K250390
Rowpar Pharmaceuticals, Inc.
Dental · 97d
Cleared Apr 19, 2024
Salivea Dry Mouth Moisturizing Gel (Dry Mouth Moisturizing Gel)
K240508
Laclede, Inc.
Dental · 58d
Cleared Mar 11, 2024
Caphosol® Artifical Saliva (32 doses sachet box)
K234015
Eusa Pharma (Uk) Limited
Dental · 83d
Cleared Aug 22, 2023
GuruNanda Dry Mouth Oral Rinse and GuruNanda Dry Mouth Oral Spray
K231205
Gurunanda, LLC
Dental · 117d
Cleared Sep 03, 2021
Dentilube Spray
K202689
Oxy2plus, LLC
Dental · 353d
Cleared Apr 05, 2021
Oral-B Dry Mouth Oral Rinse
K203567
The Procter & Gamble Company
Dental · 119d
Cleared Sep 02, 2020
Oral-B Dry Mouth Oral Rinse
K201277
The Procter & Gamble Company
Dental · 112d
Cleared Nov 21, 2019
CVS Health Dry Mouth Spray, OraLabs Dry Mouth Spray
K181839
Oralabs, Inc.
Dental · 498d
Cleared Nov 05, 2019
MucoPEG
K190144
Sunbio, Inc.
Dental · 280d
Cleared Feb 15, 2019
SmartMouth DryMouth Oral Rinse
K181194
Triumph Pharmaceuticals, Inc.
Dental · 287d
Cleared Oct 11, 2018
Salivea Dry Mouth Mouthwash, Salivea Dry Mouth Mouthspray
K180680
Laclede, Inc.
Dental · 210d
Cleared Jul 27, 2018
Voutia™
K173808
Jeffrey Ward Cash, Dds
Dental · 224d
Cleared Jul 13, 2018
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
Sunstar Americas, Inc.
Dental · 74d
Cleared Mar 19, 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.
Dental · 165d
Cleared Mar 16, 2018
TheraBreath Dry Mouth Oral Rinse, TheraBreath Dry Mouth Lozenges
K171542
Dr. Harold Katz, LLC (Dba Therabreath
Dental · 294d
Cleared Jan 27, 2011
GC ORAL MOISTURIZING GEL
K101346
GC America, Inc.
Dental · 259d

About Product Code LFD - Regulatory Context

510(k) Submission Activity

50 total 510(k) submissions under product code LFD since 1981, with 50 receiving FDA clearance (average review time: 182 days).

Submission volume has declined in recent years - 2 submissions in the last 24 months compared to 3 in the prior period.

FDA 510(k) Review Time - LFD Product Code

Recent submissions under LFD have taken an average of 95 days to reach a decision - down from 185 days historically, suggesting improved FDA processing for this classification.

LFD devices are reviewed by the Dental panel. Browse all Dental devices →