Manufacturer registered with FDA
CMS Dental A/S
Roslev, Denmark. Lists 2 dental device types with FDA across 1 registered establishment.
- Device types listed
- 2
- Brands and models
- 4
- 510(k) clearances
- 0as applicant
- Markets registered in
- 832 registrations outside the US
- Establishments
- 1Denmark
Registered in 8 markets
Where regulators' registries name CMS Dental A/S 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 | CMS Dental A/S | 2 device types | — | Below |
| Australia | TGA | Manufacturer | CMS Dental A/SCMS Dental APS | 8 | 2008–2023 | Pure Global AI |
| European Union | EUDAMED | Manufacturer | CMS Dental | 8 | — | Pure Global AI |
| Taiwan | TFDA | Manufacturer | CMS DENTALCMS DENTAL APS · CMS DENTAL A/S · +1 | 8 | 2005–2026 | Pure Global AI |
| South Korea | MFDS | Manufacturer | CMS DentalCMS Dental ApS. · CMS-Dental Aps | 5 | 2005–2015 | Pure Global AI |
| Brazil | ANVISA | Manufacturer | CMS DENTAL | 1 | 2013–2013 | Pure Global AI |
| Canada | Health Canada | Registration holder | CMS DENTAL APS | 1 | 2005–2005 | Pure Global AI |
| United Kingdom | MHRA | Manufacturer | CMS DENTAL A/S | 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 CMS Dental A/S currently lists, by FDA device type, with the brand and model names on the listing.
| Device type | Category | Role | Brands and models | Listed since |
|---|---|---|---|---|
| Ultraviolet Activator for PolymerizationEBZ · Class 2 | Curing lights | Maker | FlashMax P3 Cure &OrthoFlashMax P3 WSFlashMax P4 OrthoProFlashMax P7 LAD | 2006 |
| Gutta-PerchaEKM · Class 1 | Root canal filling materials | Maker | — | 1997 |
Source: FDA establishment registration & device listing, 510(k) and product classification files · FDA data as of 2 Nov 2026 · snapshot 12 Nov 2026
Also lists devices cleared under other names
CMS Dental A/S lists these devices with FDA today. The clearance names a different applicant, as happens after a rename, an acquisition or a private-label agreement.
Original applicants: Soft-Core Texas, Inc. (1).
| Decided | 510(k) | Device | Applicant | Device type |
|---|---|---|---|---|
| 28 Nov 2000 | K002991 | ZAP DUAL CURING LIGHT | Soft-Core Texas, Inc. | EBZ Ultraviolet Activator for Polymerization |
Registered establishments
| Establishment | Location | What it does |
|---|---|---|
| CMS DENTAL A/SFDA reg. 3002957626 | Roslev Midtjylland, Denmark | Manufacturer |
Sources
FDA establishment registration & device listing (search FDA, owner/operator 9029381). 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.