Cleared Traditional

Custom-made Invisible Aligners (K203624) - FDA 510(k) Clearance

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

K203624 · Zhejiang Yinchili Medical Technology Co., Ltd. · Dental device
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Jun 2022
Decision
552d
Days
Class 2
Risk

K203624 is an FDA 510(k) clearance for the Custom-made Invisible Aligners. Classified as Aligner, Sequential (product code NXC), Class II - Special Controls.

Submitted by Zhejiang Yinchili Medical Technology Co., Ltd. (Jiaxing, CN). The FDA issued a Cleared decision on June 16, 2022 after a review of 552 days - an unusually long review period, suggesting complex equivalence evaluation.

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: High-complexity regulatory submission. Elevated predicate reliance profile. The extended review timeline suggests the FDA required additional documentation before confirming substantial equivalence - a pattern common in complex or first-of-kind Dental submissions.

View all Zhejiang Yinchili Medical Technology Co., Ltd. devices

Submission Details

510(k) Number K203624 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 11, 2020
Decision Date June 16, 2022
Days to Decision 552 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
425d slower than avg
Panel avg: 127d · This submission: 552d
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 Consultant

Shanghai Sungo Management Consulting Company Limited.
Ivy Wang

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.

Regulatory Peers - NXC Aligner, Sequential

All 123
Devices cleared under the same product code (NXC) and FDA review panel - the closest regulatory comparables to K203624.
Clear Aligner
K213026 · Shenzhen Meiming Dentistry Technology Co., Ltd. · Aug 2022
Arkligners
K220835 · Arklign Laboratories · Aug 2022
SmileSeries
K221097 · Ordont Orthodontic Laboratories, Inc. · Jul 2022
LuxCreo Clear Aligner System
K212680 · LuxCreo, Inc. · May 2022
DailyMate Orthodontic Aligner System
K212803 · 3D Global Biotech, Inc. · May 2022
Invisalign System
K220287 · Align Technology, Inc. · Apr 2022