meddevicedb.com FDA Device Reference

ToothWave™

DEN190039 Class II Direct
Decision Date
2020-09-17
Sponsor / Applicant
Home Skinovations , Ltd.

Technical Specification

510(k) Submission ID DEN190039
Product Code QMJ
Medical Specialty / Panel Dental
Regulation Citation 21 CFR 872.6866
Decision Date 2020-09-17
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

ToothWave™ received FDA 510(k) clearance under submission number DEN190039, sponsored by Home Skinovations , Ltd.. The device was reviewed via the Direct premarket notification pathway and assigned to the Dental review panel. The statutory decision date of record is 2020-09-17.

Classification & Regulation

This clearance is catalogued under FDA product code QMJ and 21 CFR 872.6866, within the Dental review panel as a Class II device.