Cleared Traditional

K931980 - STAINLESS STEEL ORTHODONTIC PRODUCTS (FDA 510(k) Clearance)

Class I Dental device.

K931980 · Ortho Organizers, Inc. · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
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

Submission Details

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.

Device Classification

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.