Manufacturer registered with FDA
Ritter Concept GmbH
Biberach, Germany. Lists 3 dental device types with FDA across 1 registered establishment, and holds 1 510(k) clearance as applicant.
- Device types listed
- 3
- Brands and models
- 14
- 510(k) clearances
- 12016–2016
- Markets registered in
- 1034 registrations outside the US
- Establishments
- 1Germany
510(k) clearances per year, 2007–2026
Registered in 10 markets
Where regulators' registries name Ritter Concept GmbH 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 | Ritter Concept GmbH | 1 clearances | 2016–2016 | Below |
| Saudi Arabia | SFDA | Manufacturer | Ritter Concept GmbH | 12 | — | Pure Global AI |
| Taiwan | TFDA | Manufacturer | RITTER CONCEPT GMBH | 7 | 2006–2014 | Pure Global AI |
| Canada | Health Canada | Registration holder | RITTER CONCEPT GMBH | 4 | 2018–2018 | Pure Global AI |
| European Union | EUDAMED | Manufacturer | Ritter Concept GmbH | 4 | — | Pure Global AI |
| Israel | AMAR | Manufacturer | Ritter Concept GmbH | 2 | — | Pure Global AI |
| United Kingdom | MHRA | Manufacturer | Ritter Concept GmbH | 2 | — | Pure Global AI |
| Australia | TGA | Manufacturer | Ritter Concept GmbH | 1 | 2007–2007 | Pure Global AI |
| Peru | DIGEMID | Manufacturer | RITTER CONCEPT GmbH | 1 | 2013–2013 | Pure Global AI |
| Serbia | ALIMS | Manufacturer | Ritter Concept GmbH | 1 | 2024–2024 | 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 Ritter Concept GmbH currently lists, by FDA device type, with the brand and model names on the listing.
| Device type | Category | Role | Brands and models | Listed since |
|---|---|---|---|---|
| Suction Operatory UnitEBR · Class 1 | Suction & evacuation units | Maker | Ritter | 2012 |
| Operative Dental UnitEIA · Class 1 | Dental chairs & operative units | Maker | Contact LiteContact Lite ComfortContact WorldHangingSwingingUltimate ComfortUltimate Comfort SmartUltimate Comfort Smart PVanguardVanguard Dental Unit 2 moreVanguard SmartVanguard Smart P | 2020 |
| Accessories Operative Dental UnitNRD · Class 1 | — | Maker | Ritter | 2012 |
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 |
|---|---|---|
| RITTER CONCEPT GMBHFDA reg. 3008813313 | Biberach Baden-Wurttemberg, Germany | Manufacturer |
Sources
FDA establishment registration & device listing (search FDA, owner/operator 10039718). 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.