Manufacturer registered with FDA
The Cretex Companies, Inc.
Elk River, MN, United States. Lists 2 dental device types with FDA across 2 registered establishments.
- Device types listed
- 2
- Brands and models
- 1
- 510(k) clearances
- 0as applicant
- Markets registered in
- 47 registrations outside the US
- Establishments
- 2United States
Registered in 4 markets
Where regulators' registries name The Cretex Companies, Inc. 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 | The Cretex Companies, Inc. | 2 device types | — | Below |
| South Korea | MFDS | Manufacturer | RMS Surgical, Inc.RMS Surgical · rms Surgical, Inc. | 5 | 2016–2023 | Pure Global AI |
| Colombia | INVIMA | Manufacturer | RMS CO. | 1 | — | Pure Global AI |
| Taiwan | TFDA | Manufacturer | RMS Co. | 1 | 2018–2018 | 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 The Cretex Companies, Inc. currently lists, by FDA device type, with the brand and model names on the listing.
| Device type | Category | Role | Brands and models | Listed since |
|---|---|---|---|---|
| Intraosseous Fixation WireDZK · Class 2 | — | Maker | BacFix Thoracolumber Fusion System | 2013 |
| All Types RetractorEIG · Class 1 | Dental hand instruments | Maker | — | 2018 |
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 |
|---|---|---|
| RMS CO.FDA reg. 2183946 | MINNEAPOLIS, MN, United States | Contract manufacturer |
| rms SurgicalFDA reg. 3010009693 | Anoka, MN, United States | Contract manufacturer |
Other names on FDA records
RMS Co. · rms Surgical, Inc.
Sources
FDA establishment registration & device listing (search FDA, owner/operator 9001389). 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.