Manufacturer registered with FDA
Rayence Co., Ltd.
Hwaseong-si, South Korea. Lists 1 dental device type with FDA across 1 registered establishment, and holds 5 510(k) clearances as applicant.
- Device types listed
- 1
- Brands and models
- 0
- 510(k) clearances
- 52015–2022
- Markets registered in
- 1482 registrations outside the US
- Establishments
- 1South Korea
510(k) clearances per year, 2007–2026
Registered in 14 markets
Where regulators' registries name Rayence Co., Ltd. as the manufacturer or the registration holder of a device.
| Market | Regulator | Named as | Name on the registry | Registrations | Issued | Records |
|---|---|---|---|---|---|---|
| United States | FDA | Manufacturer | Rayence Co., Ltd. | 5 clearances | 2015–2022 | Below |
| Canada | Health Canada | Registration holder | RAYENCE CO., LTD. | 22 | 2009–2022 | Pure Global AI |
| European Union | EUDAMED | Manufacturer | Rayence Co., Ltd. | 22 | — | Pure Global AI |
| Taiwan | TFDA | Manufacturer | Rayence Co., Ltd.RAYENCE CO., LTD | 14 | 2009–2023 | Pure Global AI |
| Brazil | ANVISA | Manufacturer | RAYENCE CO. LTD.Rayence Co., Ltd. | 4 | 2015–2026 | Pure Global AI |
| Colombia | INVIMA | Manufacturer | RAYENCE CO., LTD. | 4 | — | Pure Global AI |
| China | NMPA | Registration holder | 韩国瑞恩思有限公司Rayence Co., Ltd. | 3 | — | Pure Global AI |
| United Kingdom | MHRA | Manufacturer | RAYENCE | 3 | — | Pure Global AI |
| Australia | TGA | Manufacturer | Rayence Co Ltd | 2 | 2015–2020 | Pure Global AI |
| Costa Rica | Ministerio de Salud | Manufacturer | Rayence Co., LtdRayence Co., Ltd. | 2 | — | Pure Global AI |
| Saudi Arabia | SFDA | Manufacturer | Rayence Co., Ltd. | 2 | — | Pure Global AI |
| Serbia | ALIMS | Manufacturer | Rayence Co., Ltd. | 2 | 2024–2026 | Pure Global AI |
| Israel | AMAR | Manufacturer | Rayence Co., Ltd | 1 | — | Pure Global AI |
| Peru | DIGEMID | Manufacturer | RAYENCE CO., LTD. | 1 | 2019–2019 | Pure Global AI |
Outside the US the count is of all the company's device registrations in that market, dental or not · matched by company name and country · registry data read 12 Nov 2026
Devices listed with FDA
What Rayence 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 |
|---|---|---|---|---|
| Digital Extraoral Source X-Ray SystemMUH · Class 2 | Dental X-ray units | Maker | — | 2012 |
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 Rayence Co., Ltd. as the applicant.
| Decided | 510(k) | Device | Device type |
|---|---|---|---|
| 6 May 2022 | K220689 | Vatech Clismile | NJM Orthodontic Ceramic Bracket |
| 10 Nov 2015 | K153060 | Digital Dental Intra Oral Sensor, EzSensor Classic, EzSensor HD, HDI-P, HDI-S | MUH Digital Extraoral Source X-Ray System |
| 19 Jul 2015 | K151707 | EzSensor Soft, EzSensor Soft i, EzSensor Bio, and EzSensor Bio i | MUH Digital Extraoral Source X-Ray System |
| 1 May 2015 | K150797 | Digital Dental Intra Oral Sensor, EzSensor Smart | MUH Digital Extraoral Source X-Ray System |
| 10 Mar 2015 | K143753 | Digital Dental Intra Oral Sensor, EzSensor Soft, EzSensor Bio | MUH Digital Extraoral Source X-Ray System |
Some of these clearances are listed with FDA today by another company: Qpix Solutions, Inc. (1).
Also lists devices cleared under other names
Rayence Co., Ltd. lists these devices with FDA today. The clearance names a different applicant, as happens after a rename, an acquisition or a private-label agreement.
Original applicants: E-Woo Technology (1).
| Decided | 510(k) | Device | Applicant | Device type |
|---|---|---|---|---|
| 2 Dec 2009 | K090526 | MEDICAL IMAGE PROCESSING UNIT, MODEL EZSENSOR | E-Woo Technology | MUH Digital Extraoral Source X-Ray System |
Registered establishments
| Establishment | Location | What it does |
|---|---|---|
| RAYENCE CO., LTD.FDA reg. 3009048384 | Hwaseong-si Gyeonggi, South Korea | Manufacturer |
Sources
FDA establishment registration & device listing (search FDA, owner/operator 10036755). 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.