Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR, NMPA) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

Navina Smart System, Navina Classic System

K-Number: K190977 · 2019-11-22

ApplicantDentsply Sirona
Decision Date2019-11-22
Product CodeKNT
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

Navina Smart System, Navina Classic System is a medical device manufactured by Dentsply Sirona. It received FDA 510(k) clearance on 2019-11-22 under approval number K190977. The device is classified under product code KNT. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Navina Smart System, Navina Classic System?

Navina Smart System, Navina Classic System is a medical device that received FDA 510(k) clearance on 2019-11-22. It is manufactured by Dentsply Sirona. The 510(k) number is K190977.

When was Navina Smart System, Navina Classic System approved by the FDA?

Navina Smart System, Navina Classic System received FDA 510(k) clearance on 2019-11-22, under approval number K190977.

What company makes Navina Smart System, Navina Classic System?

Navina Smart System, Navina Classic System is manufactured by Dentsply Sirona.

What is the FDA product code for Navina Smart System, Navina Classic System?

The FDA product code for Navina Smart System, Navina Classic System is KNT.

Related Clinical Trials

NCT07603258 Access-H20: Sensor-driven Smart Faucet Related Study COMPLETED NCT07579832 Quantitative Monitoring of Disability Care Quality for Long-Term Care Facilities 2 NOT_YET_RECRUITING NCT06657183 ECM and Monitoring w/ Alio Smart Patch in Cancer Pts Receiving Chemotherapy RECRUITING NCT07574229 Support System Design for Adolescent Scoliosis Orthosis Wear RECRUITING NCT07573540 Optimizing Smart Technology for Addiction Recovery NOT_YET_RECRUITING NCT03505801 Confirm Rx Insertable Cardiac Monitor SMART Registry COMPLETED

Other Devices by Dentsply Sirona

K161330Pour Acrylic K160825MIDWEST RDH Freedom Cordless Prophy System with SmartMode Technology K162107TPH Spectra+ Universal Composite Restorative K160626ATLANTIS Abutment for HIOSSEN ET implant K161030ATLANTIS Abutment for CONELOG implant K161269CELTRA Press

View all 65 devices →

Related Devices (Code: KNT)

K163092TubeClear Control Box and Clearing StemActuated Medical, Inc. K162110CORGRIP NG/NI Tube Retention SystemCorpak Medsystems, Inc. A Division of Haylard Health K160787Gabriel Feeding Tube with Balloon, Magnetically Guided Feeding Tube w/Balloon, Gabriel Feeding Tube with Balloon, Preassembled with StyletSyncro Medical Innovations, Inc. K152246Aquarius Stoma Measuring DeviceDegania Silicone , Ltd. K153506Qora AIM Stool Management Kit, Qora Aeon Stool Management Kit, Qora Arida Stool Management KitConsure Medical Pvt , Ltd. K160654GastriSail Gastric Positioning System 40 Fr/CH (13.3mm)Covidien, LLC

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

↑