meddevicedb.com FDA Device Reference

COMPACT S, COMPACT S (LED)

K170104 Class II Traditional
Decision Date
2017-12-27
Sponsor / Applicant
Dmetec.Co., Ltd.

Technical Specification

510(k) Submission ID K170104
Product Code ELC
Medical Specialty / Panel Dental
Regulation Citation 21 CFR 872.4850
Decision Date 2017-12-27
Clearance Pathway Traditional

Official Documentation

FDA CDRH Summary / statement of record

View FDA Summary PDF

Clearance Summary

COMPACT S, COMPACT S (LED) received FDA 510(k) clearance under submission number K170104, sponsored by Dmetec.Co., Ltd.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Dental review panel. The statutory decision date of record is 2017-12-27.

Classification & Regulation

This clearance is catalogued under FDA product code ELC and 21 CFR 872.4850, within the Dental review panel as a Class II device.