Manufacturer registered with FDA

ODS Co., Ltd.

Incheon, South Korea. Lists 4 dental device types with FDA across 1 registered establishment, and holds 1 510(k) clearance as applicant.

FDA owner/operator10074605Manufacturer1 clearance in five years

Device types listed: 4
Brands and models: 4
510(k) clearances: 12025–2025
Markets registered in: 1United States
Establishments: 1South Korea

510(k) clearances per year, 2007–2026

Devices listed with FDA

What ODS 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
Orthodontic Space Preformed MaintainerDYT · Class 1	Retainers, expanders & headgear	Maker	ODS Clear Resin - Retainer	2021
Endosseous Dental Implant AccessoriesNDP · Class 1	Implant instruments & surgical kits	Maker	ODS Surgical Guide	2020
Computer Assisted Design and Manufacturing (Cad/Cam) of Dental Restorations Optical Impression SystemNOF · Class 2	Intraoral scanners	Maker	Scan Cure (SC-80)	2023
Sequential AlignerNXC · Class 2	Clear aligners	Maker	Clear Miracle	2025

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 ODS Co., Ltd. as the applicant.

Decided	510(k)	Device	Device type
22 Jul 2025	K251616	Clear Miracle	NXC Sequential Aligner

Registered establishments

Establishment	Location	What it does
ODS CO., LTD.FDA reg. 3017210293	Incheon, South Korea	Manufacturer

Sources

FDA establishment registration & device listing (search FDA, owner/operator 10074605). 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.