Cleared Traditional

K936243 - REGENCY TUBE (FDA 510(k) Clearance)

Class I Dental device.

K936243 · Ortho Specialties · Dental device
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Feb 1994
Decision
34d
Days
Class 1
Risk

K936243 is an FDA 510(k) clearance for the REGENCY TUBE. Classified as Tube, Orthodontic (product code DZD), Class I - General Controls.

Submitted by Ortho Specialties (Hickory Hills, US). The FDA issued a Cleared decision on February 2, 1994 after a review of 34 days - a notably fast clearance 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

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Submission Details

510(k) Number K936243 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 30, 1993
Decision Date February 02, 1994
Days to Decision 34 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
93d faster than avg
Panel avg: 127d · This submission: 34d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code DZD Tube, 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.