Manufacturer registered with FDA
Autocam Medical
Kentwood, MI, United States. Lists 7 dental device types with FDA across 2 registered establishments.
- Device types listed
- 7
- Brands and models
- 0
- 510(k) clearances
- 0as applicant
- Markets registered in
- 217 registrations outside the US
- Establishments
- 2China, United States
Registered in 2 markets
Where regulators' registries name Autocam Medical 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 | Autocam Medical | 7 device types | — | Below |
| South Korea | MFDS | Manufacturer | Autocam MedicalAutocam Medical Devices (Suzhou) Co., Ltd. · Autocam Medical, LLC · +2 | 17 | 2010–2024 | 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 Autocam Medical 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 Hand InstrumentsDZN · Class 1 | Dental hand instruments | Maker | — | 2015 |
| Dental Instrument HandleEJB · Class 1 | Dental hand instruments | Maker | — | 2015 |
| Bone PlateJEY · Class 2 | Maxillofacial plates & screws | Maker | — | 2018 |
| External Mandibular Fixator and/or DistractorMQN · Class 2 | Maxillofacial plates & screws | Maker | — | 2015 |
| Temporary Mandibular Condyle ProsthesisNEI · Class 2 | — | Maker | — | 2015 |
| Endosseous Dental Implant AbutmentNHA · Class 2 | Implant abutments | Maker | — | 2015 |
| Tongue Suspension SystemORY · Class 2 | — | Maker | — | 2021 |
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 |
|---|---|---|
| Autocam MedicalFDA reg. 1057425 | Murfreesboro, TN, United States | Contract manufacturer |
| Autocam Medical Devices (Suzhou) Co. Ltd.FDA reg. 3013564228 | Suzhou Jiangsu, China | Contract manufacturer |
Other names on FDA records
Autocam Medical Devices (Suzhou) Co., Ltd.
Sources
FDA establishment registration & device listing (search FDA, owner/operator 9034301). 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.