Cleared Traditional

K990212 - LOCKJAW 15 MINUTE INTERMAXILLARY FIXATION SYSTEM,MODEL LJ100-00

K990212 is an FDA 510(k) clearance for LOCKJAW 15 MINUTE INTERMAXILLARY FIXATI..., manufactured by Doctor'S Research Group, Inc.. The device is a Class 2 Dental device with product code DYX cleared through the Traditional 510(k) pathway after a 235-day FDA review.

K990212 · Doctor'S Research Group, Inc. · Dental device
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Sep 1999
Decision
235d
Days
Class 2
Risk

K990212 is an FDA 510(k) clearance for the LOCKJAW 15 MINUTE INTERMAXILLARY FIXATION SYSTEM,MODEL LJ100-00. Classified as Lock, Wire, And Ligature, Intraoral (product code DYX), Class II - Special Controls.

Submitted by Doctor'S Research Group, Inc. (Wolcott, US). The FDA issued a Cleared decision on September 14, 1999 after a review of 235 days - an extended review cycle.

This device falls under the Dental FDA review panel, regulated under 21 CFR 872.4600 - 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 Doctor'S Research Group, Inc. devices

FDA 510(k) Submission Details - K990212

510(k) Number K990212 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 22, 1999
Decision Date September 14, 1999
Days to Decision 235 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
108d slower than avg
Panel avg: 127d · This submission: 235d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

DYX Device Classification - Class 2, Special Controls

Product Code DYX Lock, Wire, And Ligature, Intraoral
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 872.4600
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 - DYX Lock, Wire, And Ligature, Intraoral

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