Cleared Traditional

K930202 - TITAN SEPARATING SPRING

K930202 is an FDA 510(k) clearance for TITAN SEPARATING SPRING, manufactured by Ortho Spectrum, Inc.. The device is a Class 1 Dental device with product code DZC cleared through the Traditional 510(k) pathway after a 133-day FDA review.

K930202 · Ortho Spectrum, Inc. · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
May 1993
Decision
133d
Days
Class 1
Risk

K930202 is an FDA 510(k) clearance for the TITAN SEPARATING SPRING. Classified as Wire, Orthodontic (product code DZC), Class I - General Controls.

Submitted by Ortho Spectrum, Inc. (Hickory Hills, US). The FDA issued a Cleared decision on May 27, 1993 after a review of 133 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 Spectrum, Inc. devices

FDA 510(k) Submission Details - K930202

510(k) Number K930202 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 14, 1993
Decision Date May 27, 1993
Days to Decision 133 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
6d slower than avg
Panel avg: 127d · This submission: 133d
Pathway characteristics
Predicate-based equivalence.

DZC Device Classification - Class 1, General Controls

Product Code DZC Wire, 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.