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DIAETCH Economic Package Type A, DIATECH Regular Package, DIAETCH Refill Package Type A, DIAETCH Intro Kit

K192273 Class II Traditional
Decision Date
2020-02-07
Sponsor / Applicant
DiaDent Group International

Technical Specification

510(k) Submission ID K192273
Product Code KLE
Medical Specialty / Panel Dental
Regulation Citation 21 CFR 872.3200
Decision Date 2020-02-07
Clearance Pathway Traditional

Official Documentation

FDA CDRH Summary / statement of record

View FDA Summary PDF

Clearance Summary

DIAETCH Economic Package Type A, DIATECH Regular Package, DIAETCH Refill Package Type A, DIAETCH Intro Kit received FDA 510(k) clearance under submission number K192273, sponsored by DiaDent Group International. The device was reviewed via the Traditional premarket notification pathway and assigned to the Dental review panel. The statutory decision date of record is 2020-02-07.

Classification & Regulation

This clearance is catalogued under FDA product code KLE and 21 CFR 872.3200, within the Dental review panel as a Class II device.