Manufacturer registered with FDA
Complexus Medical
Mishawaka, IN, United States. Lists 3 dental device types with FDA across 1 registered establishment.
- Device types listed
- 3
- Brands and models
- 6
- 510(k) clearances
- 0as applicant
- Markets registered in
- 22 registrations outside the US
- Establishments
- 1United States
Registered in 2 markets
Where regulators' registries name Complexus 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 | Complexus Medical | 3 device types | — | Below |
| South Korea | MFDS | Manufacturer | Complexus Medical | 2 | 2026–2026 | 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 Complexus 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 |
|---|---|---|---|---|
| External Mandibular Fixator and/or DistractorMQN · Class 2 | Maxillofacial plates & screws | Maker | Set Screw Dog Point M4x5, Blue Device180mm Carbon Rod, Blue Device25mm Qc Dual Rail Distractor | 2013 |
| Dental Instrument Depth GaugeEIL · Class 1 | Dental hand instruments | Maker | Depth Gage 1.5/2, 45mm, longDepth Gage 2/2.4 45mm, long | 2013 |
| Dental Instrument HandleEJB · Class 1 | Dental hand instruments | Maker | Rapidfire Upper Driver Assembly | 2013 |
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 |
|---|---|---|
| Complexus MedicalFDA reg. 3009887475 | Mishawaka, IN, United States | Contract manufacturer |
Sources
FDA establishment registration & device listing (search FDA, owner/operator 10042212). 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.