Not currently registered with FDA under this name
Zima International Inc., dba Dandy
New York, NY, United States. Named as applicant on 1 dental 510(k) clearance between 2026 and 2026. No establishment is registered with FDA under this exact name today.
- Device types listed
- 0
- Brands and models
- 0
- 510(k) clearances
- 12026–2026
- Markets registered in
- 352 registrations outside the US
- Establishments
- 0—
510(k) clearances per year, 2007–2026
Registered in 3 markets
Where regulators' registries name Zima International Inc., dba Dandy as the manufacturer or the registration holder of a device.
RegisteredHome: United StatesOne marker per market
| Market | Regulator | Named as | Name on the registry | Registrations | Issued | Records |
|---|---|---|---|---|---|---|
| United States | FDA | Applicant | Zima International Inc., dba Dandy | 1 clearances | 2026–2026 | Below |
| Canada | Health Canada | Registration holder | ZIMA INTERNATIONAL, INC. DBA DANDY | 28 | 2025–2026 | Pure Global AI |
| United Kingdom | MHRA | Manufacturer | Zima International Inc dba Dandy | 24 | — | 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
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.