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DEXIS Titanium, KaVo IXS HD (Size 1, Size 2)

K172918 Class II Traditional
Decision Date
2017-12-18
Sponsor / Applicant
Kavo Dental Technologies, LLC

Technical Specification

510(k) Submission ID K172918
Product Code MUH
Medical Specialty / Panel Dental
Regulation Citation 21 CFR 872.1800
Decision Date 2017-12-18
Clearance Pathway Traditional

Official Documentation

FDA CDRH Summary / statement of record

View FDA Summary PDF

Clearance Summary

DEXIS Titanium, KaVo IXS HD (Size 1, Size 2) received FDA 510(k) clearance under submission number K172918, sponsored by Kavo Dental Technologies, LLC. The device was reviewed via the Traditional premarket notification pathway and assigned to the Dental review panel. The statutory decision date of record is 2017-12-18.

Classification & Regulation

This clearance is catalogued under FDA product code MUH and 21 CFR 872.1800, within the Dental review panel as a Class II device.