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510(k) K062653

Device
MOUTHKOTE ORAL MOISTURIZER, MODEL 50930-098
Applicant
PARNELL PHARMACEUTICALS, INC.
510(k) number
K062653
Product code
LFD  
Decision
Substantially Equivalent (SESE)
Decision date
2006-10-27
Date received
2006-09-07
Regulation
510(k) Premarket Notification
Classification name
Saliva, Artificial
Medical specialty
510(k) Premarket Notification // Quick Links: Skip To Main Page Content Skip To Search Skip To Topics Menu Skip To Common Links U.S. Food & Drug Administration   Follow FDA En Español Search FDA   Home Food Drugs Medical Devices
Review panel
Dental
Device class
U
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
No

Applicant Contact#

Contact
FRANCIS W PARNELL
Address
1525 Francisco Blvd., Suite 15 San Rafael CA US 94901 94901

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
K240508Salivea Dry Mouth Moisturizing Gel (Dry Mouth Moisturizing Gel)Laclede, Inc.2024-04-19
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

Legacy Summary#

summary

FDA Review#

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