GERM TERMINATOR GT 100 TOOTHBRUSH SANITIZER— 510(k) K021258

Name: FDA 510(k) clearance K021258
Creator: U.S. Food and Drug Administration
Published: 2002-05-10

Substantially Equivalent

Germ Terminator Corporation

FDA 510(k) clearance K021258 for GERM TERMINATOR GT 100 TOOTHBRUSH SANITIZER, Substantially Equivalent on 2002-05-10. Applicant: Germ Terminator Corporation. Device class: 1.

Clearance details

Applicant: Germ Terminator Corporation
Product code: Code MCF
Device class: Class 1
Regulation: 21 CFR 872.6855
Advisory panel: Dental
Date received: 2002-04-19
Decision date: 2002-05-10
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Concord, MA, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code MCF

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K023662 — PROSONIC ULTRAVIOLET TOOTHBRUSH SANITIZER2003-05-28
K003517 — OTRES TOOTHBRUSH SANITIZER MODEL TB100W2001-06-06
K901459 — DS60 TOOTHBRUSH SANITIZER1990-09-17
K896481 — PUREBRUSH ULTRAVIOLET TOOTHBRUSH SANITIZER1990-05-15

Recalls naming K021258

K-number listed on FDA's recall record

Z-2047-2016 — Germ Terminator, Toothbrush Steam Sterilization for Oral Health. Model GT100. The Germ Terminator uses steam heat to sanitize two manual toothbrushes or two toothbrush heads. Water is poured into a reservoir in the device's housing. The steam cycle is followed by a drying cycle.Class II·Terminated·Ceg Enterprises Llc·20160405

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K021258.

Data sourced from openFDA. This site is unofficial and independent of the FDA.