meddevicedb.com FDA Device Reference

Valiant Curing Light

K170101 Class II Traditional
Decision Date
2017-06-08
Sponsor / Applicant
Inter-Med/Vista Dental Products

Technical Specification

510(k) Submission ID K170101
Product Code EBZ
Medical Specialty / Panel Dental
Regulation Citation 21 CFR 872.6070
Decision Date 2017-06-08
Clearance Pathway Traditional

Official Documentation

FDA CDRH Summary / statement of record

View FDA Summary PDF

Clearance Summary

Valiant Curing Light received FDA 510(k) clearance under submission number K170101, sponsored by Inter-Med/Vista Dental Products. The device was reviewed via the Traditional premarket notification pathway and assigned to the Dental review panel. The statutory decision date of record is 2017-06-08.

Classification & Regulation

This clearance is catalogued under FDA product code EBZ and 21 CFR 872.6070, within the Dental review panel as a Class II device.