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MIS V3 Conical Connection Dental Implant System­

K163349 Class II Traditional
Decision Date
2017-05-26
Sponsor / Applicant
Mis Implants Technologies , Ltd.

Technical Specification

510(k) Submission ID K163349
Product Code DZE
Medical Specialty / Panel Dental
Regulation Citation 21 CFR 872.3640
Decision Date 2017-05-26
Clearance Pathway Traditional

Official Documentation

FDA CDRH Summary / statement of record

View FDA Summary PDF

Clearance Summary

MIS V3 Conical Connection Dental Implant System­ received FDA 510(k) clearance under submission number K163349, sponsored by Mis Implants Technologies , 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 2017-05-26.

Classification & Regulation

This clearance is catalogued under FDA product code DZE and 21 CFR 872.3640, within the Dental review panel as a Class II device.