Manufacturer registered with FDA
Instrumental Machine & Development
Warsaw, IN, United States. Lists 2 dental device types with FDA across 1 registered establishment.
- Device types listed
- 2
- Brands and models
- 2
- 510(k) clearances
- 0as applicant
- Markets registered in
- 339 registrations outside the US
- Establishments
- 1United States
Registered in 3 markets
Where regulators' registries name Instrumental Machine & Development 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 | Instrumental Machine & Development | 2 device types | — | Below |
| South Korea | MFDS | Manufacturer | Instrumental Machine & DevelopmentInstrumental Machine and Development | 38 | 2009–2026 | Pure Global AI |
| Costa Rica | Ministerio de Salud | Manufacturer | INSTRUMENTAL MACHINE & DEVELOPMENT INC, | 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 Instrumental Machine & Development currently lists, by FDA device type, with the brand and model names on the listing.
| Device type | Category | Role | Brands and models | Listed since |
|---|---|---|---|---|
| Dental Instrument HandleEJB · Class 1 | Dental hand instruments | Maker | N/A | 2016 |
| Surgical Bone ChiselEML · Class 1 | Dental hand instruments | Maker | N/A | 2016 |
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 |
|---|---|---|
| INSTRUMENTAL MACHINE & DEVELOPMENT, INC.FDA reg. 1835998 | WARSAW, IN, United States | Contract manufacturer |
Sources
FDA establishment registration & device listing (search FDA, owner/operator 9023610). 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.