Search Results
Found 1 results
510(k) Data Aggregation
K Number
K193336Device Name
Synvaza Mouth Sore and Wound Rinse, Synvaza II Mouth Sore and Wound Rinse
Manufacturer
Synedgen, Inc.
Date Cleared
2020-05-27
(177 days)
Product Code
OLR, MGO, MGQ
Regulation Number
N/AWhy did this record match?
Applicant Name (Manufacturer) :
Synedgen, Inc.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Synvaza manages the pain in many types of oral wounds, mouth sores, injuries, and ulcers of the oral mucosa. It adheres to oral tissue and forms a protective barrier between the wound and contamination. It provides the moist wound environment required for optimal wound healing. Manages pain associated with oral wounds, mouth sores, injuries and ulcers of the mouth such as: canker sores, irritation and traumatic ulcers.
Device Description
Synvaza is an oral wound rinse specifically formulated with moisturizers, humectants, and mucoadhesive biopolymers that are designed to manage the pain in many types of oral wounds, mouth sores, injuries, and ulcers of the oral mucosa. When swished around the mouth, the mucoadhesive formulation results in a temporary formation of a protective coating over the oral mucosa. The liquid also provides a moist wound environment, which is required for optimal wound healing. Synvaza is supplied in plastic bottles with and without a hand pump.
Ask a Question
Page 1 of 1