Cleared Traditional

K993224 - T-GEAR, MODEL TG/400-700

K993224 is an FDA 510(k) clearance for T-GEAR, manufactured by Dontech Products B.V.. The device is a Class 2 Dental device with product code DZB cleared through the Traditional 510(k) pathway after a 137-day FDA review.

K993224 · Dontech Products B.V. · Dental device
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Feb 2000
Decision
137d
Days
Class 2
Risk

K993224 is an FDA 510(k) clearance for the T-GEAR, MODEL TG/400-700. Classified as Headgear, Extraoral, Orthodontic (product code DZB), Class II - Special Controls.

Submitted by Dontech Products B.V. (Gorinchem, Zh, NL). The FDA issued a Cleared decision on February 11, 2000 after a review of 137 days - within the typical 510(k) review window.

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.

FDA 510(k) Submission Details - K993224

510(k) Number K993224 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 27, 1999
Decision Date February 11, 2000
Days to Decision 137 days
Submission Type Traditional
Review Panel Dental (DE)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
9d slower than avg
Panel avg: 128d · This submission: 137d
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

All 30
Devices cleared under the same product code (DZB) and FDA review panel - the closest regulatory comparables to K993224.
KELES FACEMASK
K041718 · Great Lakes Orthodontics, Ltd. · Oct 2004
MORALES PROTRACTION FACEMASK
K032392 · Ortosim, S.A. DE C.V. · Oct 2003
MULTI ADJUSTABLE FACE MASK
K000358 · Ortho Technology · Jun 2000
AFFIRM SMART RELEASABLE FORCE MODULE AND COMPLIANCE SCIENCE SYSTEM
K982088 · Ortho Kinetics Corp. · Sep 1998
CLASS III REVERSE PULL FACEMASK
K980436 · Ortho Kinetics Corp. · Apr 1998
NITOM LOCKING FACEBOW
K980245 · Ortho Kinetics Corp. · Apr 1998
K993224 · T-GEAR, MODEL TG/400-700
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