meddevicedb.com FDA Device Reference

eXciteOSA with remote and eXciteOSA without remote

DEN200018 Class II Direct
Decision Date
2021-02-05
Sponsor / Applicant
Signifier Medical Technologies

Technical Specification

510(k) Submission ID DEN200018
Product Code QNO
Medical Specialty / Panel Dental
Regulation Citation 21 CFR 872.5575
Decision Date 2021-02-05
Clearance Pathway Direct

Official Documentation

No FDA summary/statement PDF is linked for this clearance in the current dataset. Consult the product code and regulation citation above to locate predicate documentation.

Clearance Summary

eXciteOSA with remote and eXciteOSA without remote received FDA 510(k) clearance under submission number DEN200018, sponsored by Signifier Medical Technologies. The device was reviewed via the Direct premarket notification pathway and assigned to the Dental review panel. The statutory decision date of record is 2021-02-05.

Classification & Regulation

This clearance is catalogued under FDA product code QNO and 21 CFR 872.5575, within the Dental review panel as a Class II device.