Not currently registered with FDA under this name
Delma Medical Instrument (Guangzhou) Co., Ltd.
Dover, DE, United States. Named as applicant on 1 dental 510(k) clearance between 2010 and 2010. No establishment is registered with FDA under this exact name today.
- Device types listed
- 0
- Brands and models
- 0
- 510(k) clearances
- 12010–2010
- Markets registered in
- 32 registrations outside the US
- Establishments
- 0—
510(k) clearances per year, 2007–2026
Registered in 3 markets
Where regulators' registries name Delma Medical Instrument (Guangzhou) 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 | Applicant | Delma Medical Instrument (Guangzhou) Co., Ltd. | 1 clearances | 2010–2010 | Below |
| Australia | TGA | Manufacturer | Delma Medical Instrument Guangzhou Co Ltd | 1 | 2017–2017 | Pure Global AI |
| South Korea | MFDS | Manufacturer | Delma Medical Instrument(Guangzhou) Co., Ltd. | 1 | 2017–2017 | 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
510(k) clearances
Clearances on which FDA names Delma Medical Instrument (Guangzhou) Co., Ltd. as the applicant.
| Decided | 510(k) | Device | Device type |
|---|---|---|---|
| 9 Sep 2010 | K101551 | PACEMAKER HIGH-SPEED HANDPIECE MODEL PM-MQ, PM-M | EFB Dental Air-Powered Handpiece |
Some of these clearances are listed with FDA today by another company: Beyes Dental Inc (1), 3D Dental Designs and Development LLC (1).
Sources
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 of the most recent filing, which can be a US agent.