Cleared Traditional

K922984 - ORTHODONTIC BITE

K922984 is an FDA 510(k) clearance for ORTHODONTIC BITE, manufactured by American Orthodontics. The device is a Class 2 Dental device with product code LRK cleared through the Traditional 510(k) pathway after a 282-day FDA review.

K922984 · American Orthodontics · Dental device
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Mar 1993
Decision
282d
Days
Class 2
Risk

K922984 is an FDA 510(k) clearance for the ORTHODONTIC BITE. Classified as Device, Anti-snoring (product code LRK), Class II - Special Controls.

Submitted by American Orthodontics (Sheboygan, US). The FDA issued a Cleared decision on March 31, 1993 after a review of 282 days - an extended review cycle.

This device falls under the Dental FDA review panel, regulated under 21 CFR 872.5570 - 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 American Orthodontics devices

FDA 510(k) Submission Details - K922984

510(k) Number K922984 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 22, 1992
Decision Date March 31, 1993
Days to Decision 282 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
155d slower than avg
Panel avg: 127d · This submission: 282d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

LRK Device Classification - Class 2, Special Controls

Product Code LRK Device, Anti-snoring
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 872.5570
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.