Cleared Traditional

K981095 - ALIGN SYSTEM

K981095 is an FDA 510(k) clearance for ALIGN SYSTEM, manufactured by Align Technology. The device is a Class 2 Dental device with product code NXC cleared through the Traditional 510(k) pathway after a 166-day FDA review.

K981095 · Align Technology · Dental device
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Optimized for regulatory review, auditing and printing
Sep 1998
Decision
166d
Days
Class 2
Risk

K981095 is an FDA 510(k) clearance for the ALIGN SYSTEM. Classified as Aligner, Sequential (product code NXC), Class II - Special Controls.

Submitted by Align Technology (San Diego, US). The FDA issued a Cleared decision on September 8, 1998 after a review of 166 days - an extended review 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: 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 Align Technology devices

FDA 510(k) Submission Details - K981095

510(k) Number K981095 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 26, 1998
Decision Date September 08, 1998
Days to Decision 166 days
Submission Type Traditional
Review Panel Dental (DE)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
39d slower than avg
Panel avg: 127d · This submission: 166d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

NXC Device Classification - Class 2, Special Controls

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.