Cleared Traditional

MOLAR DISTALIZING ASSEMBLY (K912417) - FDA 510(k) Clearance

Class I Dental device.

K912417 · American Orthodontics · Dental device
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Dec 1991
Decision
203d
Days
Class 1
Risk

K912417 is an FDA 510(k) clearance for the MOLAR DISTALIZING ASSEMBLY. Classified as Retainer, Screw Expansion, Orthodontic (product code DYJ), Class I - General Controls.

Submitted by American Orthodontics (Sheboygan, US). The FDA issued a Cleared decision on December 20, 1991 after a review of 203 days - an extended review cycle.

This device falls under the Dental FDA review panel, regulated under 21 CFR 872.5410 - 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

Submission Details

510(k) Number K912417 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 31, 1991
Decision Date December 20, 1991
Days to Decision 203 days
Submission Type Traditional
Review Panel Dental (DE)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
76d slower than avg
Panel avg: 127d · This submission: 203d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code DYJ Retainer, Screw Expansion, Orthodontic
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 872.5410
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.