Cleared Traditional

Serafin® (K232074) - FDA 510(k) Clearance

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

K232074 · Tns Co., Ltd. · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Feb 2024
Decision
225d
Days
Class 2
Risk

K232074 is an FDA 510(k) clearance for the Serafin®. Classified as Aligner, Sequential (product code NXC), Class II - Special Controls.

Submitted by Tns Co., Ltd. (Geumcheon-Gu, KR). The FDA issued a Cleared decision on February 22, 2024 after a review of 225 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 Tns Co., Ltd. devices

Submission Details

510(k) Number K232074 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 12, 2023
Decision Date February 22, 2024
Days to Decision 225 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
98d slower than avg
Panel avg: 127d · This submission: 225d
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 K232074.
Clear Moves Aligners
K240038 · Space Maintainers Laboratories (Sml) · Apr 2024
Blue Sky Plan Software, Blue Sky Bio Aligner Z, and Blue Sky Bio Aligner Z FLX
K232653 · Blue Sky Bio, LLC · Apr 2024
TERA HARZ CLEAR
K240597 · Graphy, Inc. · Mar 2024
MESHEET
K233544 · Dentis Co., Ltd. · Feb 2024
Invisalign Palatal Expander System
K232887 · Align Technology, Inc. · Dec 2023
Byte Aligner System
K230199 · Dentsply Sirona, Inc. · Oct 2023