Cleared Traditional

K071970 - CLEAR IMAGE ALIGNER

K071970 is the FDA 510(k) clearance for CLEAR IMAGE ALIGNER by Specialty Appliance Works, Inc.. It is a Class 2 Dental device (product code NXC) cleared through the Traditional 510(k) pathway after a 70-day FDA review.

K071970 · Specialty Appliance Works, Inc. · Dental device
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Optimized for regulatory review, auditing and printing
Sep 2007
Decision
70d
Days
Class 2
Risk

K071970 is an FDA 510(k) clearance for the CLEAR IMAGE ALIGNER. Classified as Aligner, Sequential (product code NXC), Class II - Special Controls.

Submitted by Specialty Appliance Works, Inc. (Marietta, US). The FDA issued a Cleared decision on September 25, 2007 after a review of 70 days - a notably fast clearance cycle.

This device falls under the Dental FDA review panel, regulated under 21 CFR 872.5470 - 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 Specialty Appliance Works, Inc. devices

Submission Details

510(k) Number K071970 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 17, 2007
Decision Date September 25, 2007
Days to Decision 70 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
57d faster than avg
Panel avg: 127d · This submission: 70d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code NXC Aligner, Sequential
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 872.5470
Definition The Device Moves The Teeth By Continuous Gentle Force For Treatment Of Minor Tooth Malocclusion.
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Dental devices follow this clearance model.