Cleared Traditional

K200908 - iSMILE

K200908 is the FDA 510(k) clearance for iSMILE by 3D Diagnostix, Inc.. It is a Class 2 Dental device (product code NXC) cleared through the Traditional 510(k) pathway after a 260-day FDA review.

K200908 · 3D Diagnostix, Inc. · Dental device
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Dec 2020
Decision
260d
Days
Class 2
Risk

K200908 is an FDA 510(k) clearance for the iSMILE. Classified as Aligner, Sequential (product code NXC), Class II - Special Controls.

Submitted by 3D Diagnostix, Inc. (Allston, US). The FDA issued a Cleared decision on December 22, 2020 after a review of 260 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 3D Diagnostix, Inc. devices

Submission Details

510(k) Number K200908 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 06, 2020
Decision Date December 22, 2020
Days to Decision 260 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
133d slower than avg
Panel avg: 127d · This submission: 260d
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.

Regulatory Peers - NXC Aligner, Sequential

All 126
Devices cleared under the same product code (NXC) and FDA review panel - the closest regulatory comparables to K200908.
BRIUS Clear Aligners
K202792 · Brius Technologies, Inc. · Jan 2021
NEOLab Clear Aligners
K203339 · New England Ortho Lab, Inc. · Jan 2021
ClearPath Aligner
K202857 · Clearpath Orthodontics, Ltd. · Jan 2021
TP Orthodontics Clear Aligner System
K193385 · Tp Orthodontics, Inc. · Nov 2020
Concinnity Aligners
K200005 · Drake Precision Dental Laboratory, Inc. · Nov 2020
Eon Aligner
K202685 · Eon Dental Jordan, LLC · Sep 2020