Cleared Traditional

K193659 - iTero Element 5D (FDA 510(k) Clearance)

Class II Dental device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K193659 · Align Technology, Inc. · Dental device
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Mar 2020
Decision
81d
Days
Class 2
Risk

K193659 is an FDA 510(k) clearance for the iTero Element 5D. Classified as Caries Detector, Laser Light, Transmission (product code NTK), Class II - Special Controls.

Submitted by Align Technology, Inc. (San Jose, US). The FDA issued a Cleared decision on March 20, 2020 after a review of 81 days - a notably fast clearance cycle.

This device falls under the Dental FDA review panel, regulated under 21 CFR 872.1745 - 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 Align Technology, Inc. devices

Submission Details

510(k) Number K193659 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 30, 2019
Decision Date March 20, 2020
Days to Decision 81 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
46d faster than avg
Panel avg: 127d · This submission: 81d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code NTK Caries Detector, Laser Light, Transmission
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 872.1745
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.