Cleared Traditional

K160799 - GenNarino

K160799 is an FDA 510(k) clearance for GenNarino, manufactured by Saliwell , Ltd.. The device is a Class 2 Dental device with product code LTF cleared through the Traditional 510(k) pathway after a 331-day FDA review.

K160799 · Saliwell , Ltd. · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Feb 2017
Decision
331d
Days
Class 2
Risk

K160799 is an FDA 510(k) clearance for the GenNarino. Classified as Stimulator, Salivary System (product code LTF), Class II - Special Controls.

Submitted by Saliwell , Ltd. (Harutzim, IL). The FDA issued a Cleared decision on February 17, 2017 after a review of 331 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the Dental FDA review panel, regulated under 21 CFR 872.5560 - the FDA dental device regulatory framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Elevated predicate reliance profile. This clearance follows a standard predicate-based equivalence path within the Dental review framework, consistent with the majority of Class II 510(k) submissions.

View all Saliwell , Ltd. devices

FDA 510(k) Submission Details - K160799

510(k) Number K160799 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 23, 2016
Decision Date February 17, 2017
Days to Decision 331 days
Submission Type Traditional
Review Panel Dental (DE)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
203d slower than avg
Panel avg: 128d · This submission: 331d
Pathway characteristics
Predicate-based equivalence.

LTF Device Classification - Class 2, Special Controls

Product Code LTF Stimulator, Salivary System
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 872.5560
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. Clinical trial data may be submitted as supporting evidence to strengthen the substantial equivalence argument. Most Dental devices follow this clearance model.

Clinical Evidence

ClinicalTrials.gov
NCT00509808 Completed Interventional Industry-sponsored

Evaluation of an Electro-stimulator for the Treatment of Xerostomia

Safety and Performance Evaluation of an Electro-stimulator Mounted on an Intra-oral Removable Appliance (Saliwell GenNarino) for the Treatment of Xerostomia

200
Patients (est.)
1
Site
Treatment
Purpose
Triple
Masking
Condition studied Xerostomia
Study design Crossover
Eligibility All sexes · 18 Years+
Principal investigator Andy Wolff, DMD
Sponsor Saliwell Ltd. (industry)
Started 2007-01-01 → Primary completion 2008-04-01 → Completed 2010-04-01
Primary outcome
Significant symptomatic improvement
Secondary outcome
1- Increased salivary output 2- Event free use (no adverse side-effects)
Study completed - no results published. This trial concluded in 2010 but has not posted results to ClinicalTrials.gov. Completed studies without public results are common in industry-sponsored device trials; the data may be referenced in the 510(k) Summary PDF or remain unpublished.
View full study on ClinicalTrials.gov