Manufacturer registered with FDA
Good Doctors Co., Ltd.
Incheon, South Korea. Lists 4 dental device types with FDA across 1 registered establishment, and holds 5 510(k) clearances as applicant.
- Device types listed
- 4
- Brands and models
- 15
- 510(k) clearances
- 52007–2023
- Markets registered in
- 735 registrations outside the US
- Establishments
- 1South Korea
510(k) clearances per year, 2000–2026
Registered in 7 markets
Where regulators' registries name Good Doctors 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 | Good Doctors Co., Ltd. | 5 clearances | 2007–2023 | Below |
| European Union | EUDAMED | Manufacturer | Good Doctors Co., Ltd. | 16 | — | Pure Global AI |
| Australia | TGA | Manufacturer | Good Doctors Co Ltd | 8 | 2011–2026 | Pure Global AI |
| Taiwan | TFDA | Manufacturer | GOOD DOCTORS CO., LTD. | 7 | 2008–2018 | Pure Global AI |
| Israel | AMAR | Manufacturer | Good Doctors Co., Ltd | 2 | — | Pure Global AI |
| Peru | DIGEMID | Manufacturer | GOOD DOCTORS CO., LTD. | 1 | 2026–2026 | Pure Global AI |
| United Kingdom | MHRA | Manufacturer | Good Doctors 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 Good Doctors 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 |
|---|---|---|---|---|
| Ultraviolet Activator for PolymerizationEBZ · Class 2 | Curing lights | Maker | CL-DC20CL-DC21CL-DP40 (Dr's Light CHOICE)CL-DP40 (Dr's Light PRIME)DR'S LIGHTDr's Light 2Dr's Light Clever | 2007 |
| Articulation PaperEFH · Class 1 | — | Maker | OA-DCG10 | 2016 |
| Light-Induced Fluorescence Caries DetectorNBL · Class 2 | Caries detection devices | Maker | IC-WHCD100 (Inspire)Polaroid P31 | 2020 |
| Computer Assisted Design and Manufacturing (Cad/Cam) of Dental Restorations Optical Impression SystemNOF · Class 2 | Intraoral scanners | Maker | IC-DZ21(Intra Oral Camera)IC-HCN30(Intra Oral Camera)IC-HCP31(Intra Oral Camera)IC-MOZ40(Intra Oral Camera)IC-WHC50(Intra Oral Camera) | 2010 |
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 Good Doctors Co., Ltd. as the applicant.
| Decided | 510(k) | Device | Device type |
|---|---|---|---|
| 4 Aug 2023 | K223507 | CL-DP40 (Drs Light PRIME), CL-DP40 (Drs Light CHOICE) | EBZ Ultraviolet Activator for Polymerization |
| 2 Jul 2020 | K183471 | IC-WHCD100 (Inspire) | NBL Light-Induced Fluorescence Caries Detector |
| 29 May 2018 | K173157 | Dr's Light2 | EBZ Ultraviolet Activator for Polymerization |
| 24 Feb 2010 | K093751 | CL-DC20, CL-DC21 | EBZ Ultraviolet Activator for Polymerization |
| 23 Aug 2007 | K071908 | DOCTOR'S LIGHT LED DENTAL CURING LIGHT | EBZ Ultraviolet Activator for Polymerization |
Some of these clearances are listed with FDA today by another company: GC America Inc. (1), Spident Co., Ltd. (1).
Registered establishments
| Establishment | Location | What it does |
|---|---|---|
| GOOD DOCTORS CO., LTD.FDA reg. 3006621353 | Incheon Seoul, South Korea | Manufacturer |
Sources
FDA establishment registration & device listing (search FDA, owner/operator 9097123). 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.