Cleared Traditional

K103019 - KJ MASK

K103019 is an FDA 510(k) clearance for KJ MASK, manufactured by Kj Meditech Co., Ltd.. The device is a Class 2 Dental device with product code DZB cleared through the Traditional 510(k) pathway after a 240-day FDA review.

K103019 · Kj Meditech Co., Ltd. · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jun 2011
Decision
240d
Days
Class 2
Risk

K103019 is an FDA 510(k) clearance for the KJ MASK. Classified as Headgear, Extraoral, Orthodontic (product code DZB), Class II - Special Controls.

Submitted by Kj Meditech Co., Ltd. (Fullerton, US). The FDA issued a Cleared decision on June 9, 2011 after a review of 240 days - an extended review cycle.

This device falls under the Dental FDA review panel, regulated under 21 CFR 872.5500 - 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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Dental review framework, consistent with the majority of Class II 510(k) submissions.

View all Kj Meditech Co., Ltd. devices

FDA 510(k) Submission Details - K103019

510(k) Number K103019 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 12, 2010
Decision Date June 09, 2011
Days to Decision 240 days
Submission Type Traditional
Review Panel Dental (DE)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
113d slower than avg
Panel avg: 127d · This submission: 240d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

DZB Device Classification - Class 2, Special Controls

Product Code DZB Headgear, Extraoral, Orthodontic
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 872.5500
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Dental devices follow this clearance model.

Regulatory Peers - DZB Headgear, Extraoral, Orthodontic

Devices cleared under the same product code (DZB) and FDA review panel - the closest regulatory comparables to K103019.
Orthodontic Facemask
K202855 · Ita.O Italian Orthodontic System S.R.L. · Jun 2021
EXTRAORAL HEADGEAR
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ADP FACEMASK
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HOOD GEAR (TM) BREAKAWAY HEADGEAR W/ HIGH PULL
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HOOD GEAR (TM) BREAKAWAY HEADGEAR WITH NECK STRAP
K902646 · Ormco Corp. · Sep 1990
SENTRY BREAKWAY NECK STRAP
K862538 · Ormco Corp. · Jul 1986