Cleared Traditional

NITE-GUIDE (K931615) - FDA 510(k) Clearance

Class I Dental device.

K931615 · Ortho-Tain, Inc. · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Apr 1995
Decision
743d
Days
Class 1
Risk

K931615 is an FDA 510(k) clearance for the NITE-GUIDE. Classified as Positioner, Tooth, Preformed (product code KMY), Class I - General Controls.

Submitted by Ortho-Tain, Inc. (Chicago, US). The FDA issued a Cleared decision on April 14, 1995 after a review of 743 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the Dental FDA review panel, regulated under 21 CFR 872.5525 - 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: High-complexity regulatory submission. Elevated predicate reliance profile. The extended review timeline suggests the FDA required additional documentation before confirming substantial equivalence - a pattern common in complex or first-of-kind Dental submissions.

View all Ortho-Tain, Inc. devices

Submission Details

510(k) Number K931615 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 01, 1993
Decision Date April 14, 1995
Days to Decision 743 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
616d slower than avg
Panel avg: 127d · This submission: 743d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code KMY Positioner, Tooth, Preformed
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 872.5525
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.