FDA.reportPublic FDA data

510(k) K240508

Device
Salivea Dry Mouth Moisturizing Gel (Dry Mouth Moisturizing Gel)
Applicant
Laclede, Inc.
510(k) number
K240508
Product code
LFD
Decision
Substantially Equivalent (SESE)
Decision date
2024-04-19
Date received
2024-02-21
Classification name
Saliva, Artificial
Medical specialty
Unknown
Review panel
Unknown
Device class
U
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
No

Applicant Contact#

Contact
Stephen Pellico
Address
2103 E. University Dr. Rancho Dominguez CA US 90220 90220

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

Other 510(k) Records For Product Code LFD#

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K253778Allday Moisturizing RinseElevate Oral Care2026-02-27
K250390CloSYS® Dry Mouth Sensitive Mouth RinseRowpar Pharmaceuticals, Inc.2025-05-19
K234015Caphosol® Artifical Saliva (32 doses sachet box)Eusa Pharma (Uk) Limited2024-03-11
K231205GuruNanda Dry Mouth Oral Rinse and GuruNanda Dry Mouth Oral SprayGurunanda, LLC2023-08-22
K202689Dentilube SprayOxy2plus, LLC2021-09-03
K203567Oral-B Dry Mouth Oral RinseThe Procter & Gamble Company2021-04-05
K201277Oral-B Dry Mouth Oral RinseThe Procter & Gamble Company2020-09-02
K181839CVS Health Dry Mouth Spray, OraLabs Dry Mouth SprayOralabs, Inc.2019-11-21
K190144MucoPEGSunbio, Inc.2019-11-05
K181194SmartMouth DryMouth Oral RinseTriumph Pharmaceuticals, Inc.2019-02-15
K180680Salivea Dry Mouth Mouthwash, Salivea Dry Mouth MouthsprayLaclede, Inc.2018-10-11
K173808Voutia™Jeffrey Ward Cash, Dds2018-07-27
K181134G•U•M HYDRAL Dry Mouth Oral Gel, G•U•M HYDRAL Dry Mouth Oral Rinse, G•U•M HYDRAL Dry Mouth Oral SpraySunstar Americas, Inc.2018-07-13
K173237Moisyn Dry Mouth Oral Rinse, Moisyn Dry Mouth Oral Mist, Moisyn Free Dry Mouth Oral Rinse, Moisyn Free Dry Mouth Oral MistSyendgen, Inc.2018-03-19
K171542TheraBreath Dry Mouth Oral Rinse, TheraBreath Dry Mouth LozengesDr. Harold Katz, LLC (Dba Therabreath2018-03-16