Manufacturer registered with FDA
Sicat GmbH & Co. KG
BONN, Germany. Lists 6 dental device types with FDA across 1 registered establishment, and holds 1 510(k) clearance as applicant.
- Device types listed
- 6
- Brands and models
- 10
- 510(k) clearances
- 12016–2016
- Markets registered in
- 1144 registrations outside the US
- Establishments
- 1Germany
510(k) clearances per year, 2007–2026
Registered in 11 markets
Where regulators' registries name Sicat GmbH & Co. KG 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 | Sicat GmbH & Co. KG | 1 clearances | 2016–2016 | Below |
| Canada | Health Canada | Registration holder | SICAT GMBH & CO. KG | 13 | 2007–2019 | Pure Global AI |
| Australia | TGA | Manufacturer | SICAT GmbH & Co KG | 8 | 2017–2025 | Pure Global AI |
| Israel | AMAR | Manufacturer | SICAT GMBH & CO. KG | 7 | — | Pure Global AI |
| European Union | EUDAMED | Manufacturer | SICAT GmbH & Co. KG | 5 | — | Pure Global AI |
| United Kingdom | MHRA | Manufacturer | SICAT GmbH & Co. KG | 4 | — | Pure Global AI |
| South Korea | MFDS | Manufacturer | SICAT GmbH & Co.KG | 2 | 2013–2019 | Pure Global AI |
| Taiwan | TFDA | Manufacturer | SICAT GmbH & Co. KG | 2 | 2020–2020 | Pure Global AI |
| Brazil | ANVISA | Manufacturer | SICAT GMBH & CO. KG | 1 | 2020–2020 | Pure Global AI |
| Costa Rica | Ministerio de Salud | Manufacturer | SICAT GmbH & Co. KG | 1 | — | Pure Global AI |
| Saudi Arabia | SFDA | Manufacturer | SICAT GmbH & Co. KG | 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 Sicat GmbH & Co. KG currently lists, by FDA device type, with the brand and model names on the listing.
| Device type | Category | Role | Brands and models | Listed since |
|---|---|---|---|---|
| Intraoral Dental DrillDZA · Class 1 | Surgical drills & motors | Lister | Endo Dental Bur | 2018 |
| Dental BurEJL · Class 1 | Dental burs & diamonds | Maker | SICAT ACCESSGUIDE | 2018 |
| Jaw Repositioning DeviceLQZ · Class 2 | Anti-snoring & jaw-repositioning devices | Maker | SICAT OPTISLEEP | 2016 |
| Anti-Snoring DeviceLRK · Class 2 | Anti-snoring & jaw-repositioning devices | Maker | SICAT OPTISLEEP | 2016 |
| Endosseous Dental Implant AccessoriesNDP · Class 1 | Implant instruments & surgical kits | Maker | SICAT BITE PLATESICAT SURGICAL GUIDEStecoGuide | 2007 |
| Jaw Tracking Device for Monitoring Jaw PositionsNFS · Class 1 | — | Lister | Fusion BiteFusion Bite AdapterParaocclusal Attachment | 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 |
|---|---|---|
| SICAT GMBH & CO. KGFDA reg. 3006098230 | BONN North Rhine-Westphalia, Germany | Foreign exporter, Manufacturer |
Sources
FDA establishment registration & device listing (search FDA, owner/operator 9087842). 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.