Manufacturer registered with FDA
Renewmedical Co., Ltd.
Bucheon-si, Gyeonggi-do, South Korea. Lists 2 dental device types with FDA across 1 registered establishment.
- Device types listed
- 2
- Brands and models
- 5
- 510(k) clearances
- 0as applicant
- Markets registered in
- 43 registrations outside the US
- Establishments
- 1South Korea
Registered in 4 markets
Where regulators' registries name Renewmedical 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 | Renewmedical Co., Ltd. | 2 device types | — | Below |
| Canada | Health Canada | Registration holder | RENEW MEDICAL, INC. | 1 | 2011–2011 | Pure Global AI |
| China | NMPA | Registration holder | 瑞新医疗株式会社Renew Medical Co., Ltd. | 1 | — | Pure Global AI |
| Colombia | INVIMA | Manufacturer | RENEW MEDICAL CO., LTD | 1 | — | 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 Renewmedical 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 |
|---|---|---|---|---|
| Resin Impression Tray MaterialEBH · Class 1 | Impression trays | Maker | Renew Tray G-1, Renew Tray G-2, Renew Tray G-3, Renew Tray G-4, Renew Tray G-5Renew Tray MG-2, Renew Tray MG-4, Renew Tray MG-7, Renew Tray MP-2Renew Tray MP-4, Renew Tray MP-7, Renew Tray RG-1, Renew Tray RG-3Renew Tray P-1, Renew Tray P-2, Renew Tray P-3, Renew Tray P-4, Renew Tray P-5 | 2024 |
| Articulation PaperEFH · Class 1 | — | Maker | Renew SHIMSTOCK | 2024 |
Source: FDA establishment registration & device listing, 510(k) and product classification files · FDA data as of 2 Nov 2026 · snapshot 12 Nov 2026
Registered establishments
| Establishment | Location | What it does |
|---|---|---|
| RENEWMEDICAL CO., LTD.FDA reg. 3018799047 | Bucheon-si, Gyeonggi-do, South Korea | Manufacturer |
Sources
FDA establishment registration & device listing (search FDA, owner/operator 10092066). 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.