Cleared Traditional

Ensmile (K222619) - FDA 510(k) Clearance

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

K222619 · Ensmile Pvt, Ltd. · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Mar 2023
Decision
198d
Days
Class 2
Risk

K222619 is an FDA 510(k) clearance for the Ensmile. Classified as Aligner, Sequential (product code NXC), Class II - Special Controls.

Submitted by Ensmile Pvt, Ltd. (Johar Town, PK). The FDA issued a Cleared decision on March 16, 2023 after a review of 198 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 Ensmile Pvt, Ltd. devices

Submission Details

510(k) Number K222619 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 30, 2022
Decision Date March 16, 2023
Days to Decision 198 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
71d slower than avg
Panel avg: 127d · This submission: 198d
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 123
Devices cleared under the same product code (NXC) and FDA review panel - the closest regulatory comparables to K222619.
STR8 Clear Aligner
K223141 · Str8 Oral Care · Apr 2023
Custom-made Invisible Aligners
K223454 · Zhejiang Yinchili Medical Technology Co., Ltd. · Apr 2023
Nightwear Aligners
K221537 · Smylio, Inc. · Apr 2023
Blue Sky Bio Aligner G & Blue Sky Plan S/W for Blue Sky Bio Aligner G
K221845 · Blue Sky Bio, LLC · Feb 2023
Toothsi, Smilealigners
K223338 · Makeo Healthcare Technologies Private Limited · Feb 2023
Invisalign System, Pre-Formed Attachment System
K222894 · Align Technology, Inc. · Dec 2022