Manufacturer registered with FDA
ACME Tooling Technology Co., Ltd.
Fuxing Township, Taiwan. Lists 3 dental device types with FDA across 1 registered establishment.
- Device types listed
- 3
- Brands and models
- 2
- 510(k) clearances
- 0as applicant
- Markets registered in
- 410 registrations outside the US
- Establishments
- 1Taiwan
Registered in 4 markets
Where regulators' registries name ACME Tooling Technology 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 | ACME Tooling Technology Co., Ltd. | 3 device types | — | Below |
| European Union | EUDAMED | Manufacturer | ACME TOOLING TECHNOLOGY CO., LTD. | 8 | — | Pure Global AI |
| Australia | TGA | Manufacturer | ACME Tooling Technology Co Ltd | 1 | 2024–2024 | Pure Global AI |
| Israel | AMAR | Manufacturer | ACME Tooling Technology 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 ACME Tooling Technology 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 |
|---|---|---|---|---|
| Mouth MirrorEAX · Class 1 | Dental hand instruments | Maker | Motranser | 2019 |
| Accessories Operative Dental UnitNRD · Class 1 | — | Maker | Intra-oral camera | 2023 |
| Intraoral CameraQJK · Class 2 | Intraoral cameras | Maker | — | 2025 |
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 |
|---|---|---|
| ACME TOOLING TECHNOLOGY CO., LTD.FDA reg. 3016232381 | Fuxing Township Changhua, Taiwan | Contract manufacturer, Foreign exporter, Manufacturer |
Sources
FDA establishment registration & device listing (search FDA, owner/operator 10062022). 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.