GenNarino Salivary Stimulator
by Saliwell, Ltd. 510(k)
Active
510(k) K160799
Overview
The GenNarino is an electrical salivary stimulatory system, classified under the FDA’s regulation 21 CFR 872.5560. It functions as a device designed to stimulate salivary glands through electrostimulation of associated nerves, promoting saliva production. This system is intended for use in dental applications, where adequate saliva flow is critical for patient comfort and procedural success. Its primary mechanism involves delivering controlled electrical impulses to nerve pathways linked to salivary secretion, aiding in managing dry mouth conditions.
The GenNarino is supplied as a reusable medical device, intended for use in clinical dental settings. It is not sterile at the time of shipment and must be cleaned and maintained according to manufacturer guidelines before each use. The device is classified as Class II under FDA regulations, with a product code of LTF, and is authorized via a 510(k) clearance (K160799). No specific MRI safety information is provided, and storage conditions should follow standard electrical medical equipment protocols to ensure proper functionality and hygiene.
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK160799 | Date17 Feb 2017 | StatusActive |
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not known
- Not covered
United States — FDA 510(k) Active
Recalls
No FDA recalls on record, checked 5 Oct 2026.
Specification
- Full name
- GenNarino
- 510(k) Number
- FDA Product Code
- LTF
- FDA applicant
- Saliwell , Ltd.
- Device Class
- Class II
- Regulation
- 21 CFR Part 872.5560
- Advisory Committee
- Dental
- FDA Decision
- SESE Substantially Equivalent
Other devices from Saliwell, Ltd.
Questions
What is the GenNarino used for in dental applications?
The GenNarino is designed to stimulate salivary glands through controlled electrical impulses delivered to nerves associated with saliva production. This helps manage dry mouth conditions, ensuring patient comfort and procedural success during dental treatments where saliva flow is critical.
Is the GenNarino a single-use or reusable device?
The GenNarino is a reusable medical device intended for clinical dental settings. It must be cleaned and maintained according to manufacturer guidelines before each use, as it is not sterile at the time of shipment.
How should the GenNarino be stored?
Storage should follow standard protocols for electrical medical equipment to maintain functionality and hygiene. Ensure the device is kept in a clean, dry environment and protected from physical damage or exposure to moisture.
Does the GenNarino have any specific MRI safety information?
No specific MRI safety information is provided for the GenNarino. Clinicians should consult manufacturer guidelines and follow standard safety protocols when using electrical medical devices near MRI environments.
What regulatory pathway does the GenNarino follow?
The GenNarino is classified as a Class II device under FDA regulations and has received a 510(k) clearance (K160799) through the traditional review pathway. It is substantially equivalent to a predicate device and falls under the product code LTF for dental applications.