meddevicedb.com FDA Device Reference

MATRx plus

DEN170090 Class II Direct
Decision Date
2018-08-23
Sponsor / Applicant
Zephyr Sleep Technologies

Technical Specification

510(k) Submission ID DEN170090
Product Code QCJ
Medical Specialty / Panel Dental
Regulation Citation 21 CFR 872.5571
Decision Date 2018-08-23
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

MATRx plus received FDA 510(k) clearance under submission number DEN170090, sponsored by Zephyr Sleep 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 2018-08-23.

Classification & Regulation

This clearance is catalogued under FDA product code QCJ and 21 CFR 872.5571, within the Dental review panel as a Class II device.