Model: Mouth Kote 2oz
Catalog: 098-02
DI: 00350930098029
Status: New
MRI: Labeling does not contain MRI Safety Information
Single-use: No
Rx: No
OTC: Yes
First Published: 2026-05-21
Current Version: 2026-05-29
Description
Relieves Dry Mouth Conditions
Sterilization
Device Sterile:
No
Sterilization Prior To Use:
No
Regulatory & Distribution
Record Status:
Published
Version Number:
1
Record Key:
336fc0fc-c413-4e8d-a187-9feecfca1ab0
Distribution Status:
In Commercial Distribution
DUNS Number:
022926067
Device Count:
1
DM Exempt:
No
Premarket Exempt:
No
HCT/P:
No
Kit:
No
Combination Product:
No
Lot/Batch Tracked:
Yes
Serial Number Tracked:
No
Manufacturing Date Tracked:
No
Expiration Date Tracked:
Yes
Donation ID Number Tracked:
No
Labeled Contains NRL:
No
Labeled No NRL:
No
Identifiers
Device ID:
00350930098029
Type:
Primary
Issuing Agency:
GS1
GMDN
Code: 42345
Name: Dental mouthwash
Definition:
A substance intended to be used to clean and disinfect the oral cavity (including teeth and gums) for personal hygiene and/or dental clinical procedures. It is available in various forms (e.g., liquid solution, dissolving tablets) which inhibit bacterial growth and sometimes provide specific benefits for teeth (e.g., fluoride, whitening agents). It is intended for use in the home or a clinical setting. This is a single-use device.
FDA Product Codes
LFD
Saliva, Artificial
Premarket Submissions
Submission Number:
K062653
Supplement Number:
000