Cleared Traditional

K021258 - GERM TERMINATOR GT 100 TOOTHBRUSH SANITIZER

K021258 is an FDA 510(k) clearance for GERM TERMINATOR GT 100 TOOTHBRUSH SANITIZER, manufactured by Germ Terminator Corporation. The device is a Class 1 Dental device with product code MCF cleared through the Traditional 510(k) pathway after a 21-day FDA review.

K021258 · Germ Terminator Corporation · Dental device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
May 2002
Decision
21d
Days
Class 1
Risk

K021258 is an FDA 510(k) clearance for the GERM TERMINATOR GT 100 TOOTHBRUSH SANITIZER. Classified as Unit, Ultraviolet Sanitation/sterilization (for Toothbrushes), Sterile (product code MCF), Class I - General Controls.

Submitted by Germ Terminator Corporation (Concord, US). The FDA issued a Cleared decision on May 10, 2002 after a review of 21 days - a notably fast clearance cycle.

This device falls under the Dental FDA review panel, regulated under 21 CFR 872.6855 - the FDA dental device regulatory framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

FDA 510(k) Submission Details - K021258

510(k) Number K021258 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 19, 2002
Decision Date May 10, 2002
Days to Decision 21 days
Submission Type Traditional
Review Panel Dental (DE)
Summary Summary PDF
Third-party Review Yes - reviewed by an FDA-accredited third party
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
107d faster than avg
Panel avg: 128d · This submission: 21d
Pathway characteristics
Predicate-based equivalence. Third-party reviewed.

MCF Device Classification - Class 1, General Controls

Product Code MCF Unit, Ultraviolet Sanitation/sterilization (for Toothbrushes), Sterile
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 872.6855
What this classification means

Class I devices are subject to general controls only and most are exempt from 510(k) premarket notification. They represent the lowest regulatory burden in the FDA device framework.

Regulatory Consultant

Intertek Testing Services
DONALD J SHERRATT

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.

Regulatory Peers - MCF Unit, Ultraviolet Sanitation/sterilization (for Toothbrushes), Sterile

Devices cleared under the same product code (MCF) and FDA review panel - the closest regulatory comparables to K021258.
PROSONIC ULTRAVIOLET TOOTHBRUSH SANITIZER
K023662 · Hwadong International Company , Ltd. · May 2003
OTRES TOOTHBRUSH SANITIZER MODEL TB100W
K003517 · Otres, LLC · Jun 2001
DS60 TOOTHBRUSH SANITIZER
K901459 · Associated Mills, Inc. · Sep 1990
PUREBRUSH ULTRAVIOLET TOOTHBRUSH SANITIZER
K896481 · Purebrush Assoc. · May 1990
K021258 · GERM TERMINATOR GT 100 TOOTHBRUSH SANITIZER
Download PDF FDA Summary Germ Terminator Corpo…