Cleared Traditional

K931980 - STAINLESS STEEL ORTHODONTIC PRODUCTS

K931980 is an FDA 510(k) clearance for STAINLESS STEEL ORTHODONTIC PRODUCTS, manufactured by Ortho Organizers, Inc.. The device is a Class 1 Dental device with product code DYO cleared through the Traditional 510(k) pathway after a 132-day FDA review.

K931980 · Ortho Organizers, Inc. · Dental device
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Sep 1993
Decision
132d
Days
Class 1
Risk

K931980 is an FDA 510(k) clearance for the STAINLESS STEEL ORTHODONTIC PRODUCTS. Classified as Band, Material, Orthodontic (product code DYO), Class I - General Controls.

Submitted by Ortho Organizers, Inc. (San Marcos, US). The FDA issued a Cleared decision on September 1, 1993 after a review of 132 days - within the typical 510(k) review window.

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 Ortho Organizers, Inc. devices

FDA 510(k) Submission Details - K931980

510(k) Number K931980 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 22, 1993
Decision Date September 01, 1993
Days to Decision 132 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
5d slower than avg
Panel avg: 127d · This submission: 132d
Pathway characteristics
Predicate-based equivalence.

DYO Device Classification - Class 1, General Controls

Product Code DYO Band, Material, 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.