Itus Mouthguardz

Basic Information

• Brand Name: Itus Mouthguardz
• Primary DI: 00860002336596
• Version / Model: SilentZPro 2.0 (with clips, medium)
• Catalog Number: B0F4P7XQMC
• Company Name: Shinrin-Yoku Traders LLC
• Labeler DUNS: 117177695
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2025-08-25
• Public Version: 2
• Public Version Date: 2026-03-24
• Public Version Status: Update
• Public Device Record Key: a318ba29-7fb4-4a44-99b4-561ed1991c65

Device Description

Anti-snore mouthpiece. SilentZPro 2.0, clear, medium, with nose clips

Device Characteristics

• Single Use: No
• Prescription Use (Rx): No
• Over the Counter (OTC): Yes
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: No
• Has Lot/Batch Number: No
• Has Manufacturing Date: Yes
• Has Expiration Date: No
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
LRK	Device, Anti-Snoring	Dental	872.5570	2

GMDN Terms

Code	Name	Definition	Implantable	Status
43467	Breathing mouthpiece, reusable	A device designed for partial insertion into a patient's mouth (in between the lips) to facilitate access to the respiratory system. It is typically a small rigid or semi-rigid hollow device with a shape and structure that enables an appropriate gastight seal and prevents collapse. The device accepts or attaches to, either directly or through other tubes/adapters, diagnostic/therapeutic respiratory devices (e.g., ventilator, inhaler, incentive spirometer, aerosol equipment, breath analyser). Some types generate a whistling sound to guide effective inhalation [e.g., during use of a metered dose inhaler (MDI)]. This is a reusable device which may be intended for single- or multi-patient use.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00860002336596	GS1

Premarket Submissions

Submission Number	Supplement Number
K220688	000