Manufacturer registered with FDA
Coral Healthcare Products Manufacturer Co., Ltd.
Yangzhou, China. Lists 6 dental device types with FDA across 1 registered establishment.
- Device types listed
- 6
- Brands and models
- 15
- 510(k) clearances
- 0as applicant
- Markets registered in
- 725 registrations outside the US
- Establishments
- 1China
Registered in 7 markets
Where regulators' registries name Coral Healthcare Products Manufacturer 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 | Coral Healthcare Products Manufacturer Co., Ltd. | 6 device types | — | Below |
| Australia | TGA | Manufacturer | Coral Healthcare Products Manufacturer Co Ltd | 8 | 2024–2026 | Pure Global AI |
| Colombia | INVIMA | Manufacturer | CORAL HEALTHCARE PRODUCTS MANUFACTURER CO., LTD. | 7 | — | Pure Global AI |
| European Union | EUDAMED | Manufacturer | CORAL HEALTHCARE PRODUCTS MANUFACTURER CO., LTD | 5 | — | Pure Global AI |
| Peru | DIGEMID | Manufacturer | CORAL HEALTHCARE PRODUCTS MANUFACTURER CO., LTD. | 2 | 2018–2024 | Pure Global AI |
| South Korea | MFDS | Manufacturer | CORAL HEALTHCARE PRODUCTS MANUFACTURER CO., LTDCORAL HEALTHCARE PRODUCTS MANUFACTURER CO., LTD. | 2 | 2026–2026 | Pure Global AI |
| Brazil | ANVISA | Manufacturer | CORAL HEALTHCARE PRODUCTS MANUFACTURER CO., LTD. | 1 | 2023–2023 | 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 Coral Healthcare Products Manufacturer 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 |
|---|---|---|---|---|
| Mouth MirrorEAX · Class 1 | Dental hand instruments | Maker | DENTAL MIRROR, Brand: CORALCLEAN, USOP, SKY DENTAL, ALLURE ORTHO, PLATYPUS, O&S DENTAL; Model: D603, D653, S451, S452DENTAL MIRROR, Brand: CORALCLEAN, USOP, SKY DENTAL, ALLURE ORTHO, PLATYPUS, O&S DENTAL; Model: S453, DM01, AC01DENTAL MIRROR, Brand: CORALCLEAN, USOP, SKY DENTAL, ALLURE ORTHO, PLATYPUS, O&S DENTAL; Model: S815, S811, S951, D600 | 2022 |
| Orthodontic Bracket AlignerECQ · Class 1 | Dental hand instruments | Maker | ALIGNER CHEWIES, Brand: CORALCLEAN, USOP, SKY DENTAL, ALLURE ORTHO, PLATYPUS, O&S DENTAL; Model: D603, D653, S451, S452,ALIGNER CHEWIES, Brand: CORALCLEAN, USOP, SKY DENTAL, ALLURE ORTHO, PLATYPUS, O&S DENTAL; Model: S453, DM01, AC01ALIGNER CHEWIES, Brand: CORALCLEAN, USOP, SKY DENTAL, ALLURE ORTHO, PLATYPUS, O&S DENTAL; Model: S815, S811, S951, D600 | 2022 |
| Manual ToothbrushEFW · Class 1 | Toothbrushes | Maker | O&S DENTAL, DonnaMax, BioSwish, YS, YES STUDIO; Model: S311, S812, S815, S811, S898S951, C116, C126, C132, C885, C928, F941, F947, C906, C914, C916, 845TOOTHBRUSH, Brand: CoralClean, USOP, SKY DENTAL, ALLURE ORTHO, PLATYPUS | 2022 |
| Intraoral Dental WaxEGD · Class 1 | — | Maker | DENTAL WAX, Brand: CORALCLEAN, USOP, SKY DENTAL, ALLURE ORTHO, PLATYPUS, O&S DENTAL; Model: AC01DENTAL WAX, Brand: CORALCLEAN, USOP, SKY DENTAL, ALLURE ORTHO, PLATYPUS, O&S DENTAL; Model: D653, S451, S452, S453, DM01DENTAL WAX, Brand: CORALCLEAN, USOP, SKY DENTAL, ALLURE ORTHO, PLATYPUS, O&S DENTAL; Model: S815, S811, S951, D600, D603 | 2022 |
| Dental FlossJES · Class 1 | Floss & interdental cleaners | Maker | Bioswiss, YS, YES STUDIO; Model: D600, D601, D603, D610, D625, D653, D656DENTAL FLOSS, Brand: CoralClean, USOP, SKY Dental, ALLURE ORTHO, PLATYPUS, O&S DENTAL, DonnaMaxK1, K3, K4,K6, K7, FT01, FT02, FT03, FT08, FT09, FTS451, S432, S672, S673 | 2022 |
| Tongue ScraperLCN · Class 1 | — | Maker | — | 2023 |
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 |
|---|---|---|
| CORAL HEALTHCARE PRODUCTS MANUFACTURER CO., LTD.FDA reg. 3013645257 | YANGZHOU Jiangsu, China | Manufacturer |
Sources
FDA establishment registration & device listing (search FDA, owner/operator 10083948). 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.