Manufacturer registered with FDA

Tns Co., Ltd.

Geumcheon-gu, Seoul, South Korea. Lists 1 dental device type with FDA across 1 registered establishment, and holds 2 510(k) clearances as applicant.

FDA owner/operator10090257ManufacturerRepacker / relabeler2 clearances in five years

Device types listed: 1
Brands and models: 1
510(k) clearances: 22024–2025
Markets registered in: 1United States
Establishments: 1South Korea

510(k) clearances per year, 2007–2026

Devices listed with FDA

What Tns Co., Ltd. currently lists, by FDA device type, with the brand and model names on the listing.

Device type	Category	Role	Brands and models	Listed since
Sequential AlignerNXC · Class 2	Clear aligners	Maker	Serafin®	2024

Source: FDA establishment registration & device listing, 510(k) and product classification files · FDA data as of 2 Nov 2026 · snapshot 12 Nov 2026

510(k) clearances

Clearances on which FDA names Tns Co., Ltd. as the applicant.

Decided	510(k)	Device	Device type
11 Sep 2025	K251758	Serafin®	NXC Sequential Aligner
22 Feb 2024	K232074	Serafin®	NXC Sequential Aligner

Registered establishments

Establishment	Location	What it does
TNS CO.,LTDFDA reg. 3017220679	Geumcheon-gu, Seoul, South Korea	Complaint file establishment, Manufacturer, Repacker / relabeler

Sources

FDA establishment registration & device listing (search FDA, owner/operator 10090257). FDA 510(k) premarket notification file. FDA data as of 2 Nov 2026; snapshot 12 Nov 2026. The location shown is the address on FDA's record.