Manufacturer registered with FDA
IDM Tooling LLC
Carrollton, TX, United States. Lists 2 dental device types with FDA across 1 registered establishment.
- Device types listed
- 2
- Brands and models
- 8
- 510(k) clearances
- 0as applicant
- Markets registered in
- 21 registrations outside the US
- Establishments
- 1United States
Registered in 2 markets
Where regulators' registries name IDM Tooling LLC 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 | IDM Tooling LLC | 2 device types | — | Below |
| Taiwan | TFDA | Manufacturer | IDM TOOLING LLC | 1 | 2019–2019 | 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 IDM Tooling LLC currently lists, by FDA device type, with the brand and model names on the listing.
| Device type | Category | Role | Brands and models | Listed since |
|---|---|---|---|---|
| Orthodontic Bracket AlignerECQ · Class 1 | Dental hand instruments | Maker | ClenchyClenchy 2Clenchy Tongue CleanerClenchy U | 2019 |
| Orthodontic Band PusherECS · Class 1 | Dental hand instruments | Maker | ClenchyClenchy 2Clenchy Tongue CleanerClenchy U | 2024 |
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 |
|---|---|---|
| IDM TOOLING LLCFDA reg. 3015266919 | Carrollton, TX, United States | Specification developer |
Sources
FDA establishment registration & device listing (search FDA, owner/operator 10059892). 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.