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GERM TERMINATOR GT 100 TOOTHBRUSH SANITIZER

K021258 Class I Traditional
Decision Date
2002-05-10
Sponsor / Applicant
Germ Terminator Corporation

Technical Specification

510(k) Submission ID K021258
Product Code MCF
Medical Specialty / Panel Dental
Regulation Citation 21 CFR 872.6855
Decision Date 2002-05-10
Clearance Pathway Traditional

Official Documentation

FDA CDRH Summary / statement of record

View FDA Summary PDF

Clearance Summary

GERM TERMINATOR GT 100 TOOTHBRUSH SANITIZER received FDA 510(k) clearance under submission number K021258, sponsored by Germ Terminator Corporation. The device was reviewed via the Traditional premarket notification pathway and assigned to the Dental review panel. The statutory decision date of record is 2002-05-10.

Classification & Regulation

This clearance is catalogued under FDA product code MCF and 21 CFR 872.6855, within the Dental review panel as a Class I device.