Cleared Traditional

BILATERAL INFANT CLEFT PALATE ORTHODONTIC APPLIANCE (K970930) - FDA 510(k) Clearance

Class I Dental device.

K970930 · Cleft Palate Appliances, Inc. · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Apr 1997
Decision
41d
Days
Class 1
Risk

K970930 is an FDA 510(k) clearance for the BILATERAL INFANT CLEFT PALATE ORTHODONTIC APPLIANCE. Classified as Retainer, Screw Expansion, Orthodontic (product code DYJ), Class I - General Controls.

Submitted by Cleft Palate Appliances, Inc. (London, CA). The FDA issued a Cleared decision on April 23, 1997 after a review of 41 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.

View all Cleft Palate Appliances, Inc. devices

Submission Details

510(k) Number K970930 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 13, 1997
Decision Date April 23, 1997
Days to Decision 41 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
86d faster than avg
Panel avg: 127d · This submission: 41d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code DYJ Retainer, Screw Expansion, 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.