Manufacturer registered with FDA
Ritter Implants GmbH and Co. KG
San Antonio, TX, United States. Lists 5 dental device types with FDA across 2 registered establishments, and holds 2 510(k) clearances as applicant.
- Device types listed
- 5
- Brands and models
- 102
- 510(k) clearances
- 22016–2019
- Markets registered in
- 9238 registrations outside the US
- Establishments
- 2Germany, United States
510(k) clearances per year, 2007–2026
Registered in 9 markets
Where regulators' registries name Ritter Implants GmbH and 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 | Ritter Implants GmbH and Co. KG | 2 clearances | 2016–2019 | Below |
| Canada | Health Canada | Registration holder | RITTER IMPLANTS GMBH & CO. KG | 179 | 2019–2024 | Pure Global AI |
| Saudi Arabia | SFDA | Manufacturer | Ritter Implants GmbH & Co. KGRitter Implants GmbH & CO. KG | 16 | — | Pure Global AI |
| European Union | EUDAMED | Manufacturer | Ritter Implants GmbH & Co. KG | 13 | — | Pure Global AI |
| United Kingdom | MHRA | Manufacturer | Ritter Implants GmbH & Co.KG | 13 | — | Pure Global AI |
| Taiwan | TFDA | Manufacturer | RITTER IMPLANTS GMBH & CO. KGRITTER IMPLANTS GMBH & CO KG | 9 | 2014–2021 | Pure Global AI |
| Colombia | INVIMA | Registration holder | RITTER IMPLANTS GMBH & CO. KG | 6 | — | Pure Global AI |
| Costa Rica | Ministerio de Salud | Manufacturer | RITTER IMPLANTS GmbH & Co. KG | 1 | — | Pure Global AI |
| Israel | AMAR | Manufacturer | Ritter Implants 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 Ritter Implants GmbH and 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 |
|---|---|---|---|---|
| Root-Form Endosseous ImplantDZE · Class 2 | Dental implants | Maker | Ritter Dental Implant SystemRitter DentalsRitter Implant system small sizes | 2014 |
| Endosseous Dental Implant AbutmentNHA · Class 2 | Implant abutments | Maker | Ritter Dental Implant SystemRitter DentalsRitter Implant system small sizes | 2014 |
| Intraoral Dental DrillDZA · Class 1 | Surgical drills & motors | Maker | CD-2.5CD-2.8CD-3CD-3.3CD-3.75CD-3.75-4.2CD-4.2CD-5CD-5-6CD-6 85 moreCDE-1.8-2.4CDE-2-3.2CDE-2.5-3.7CDE-2.7-4CDE-2.7-4.5CDE-3.1-5.5CDEP-2.5-10CDEP-2.5-11.5CDEP-2.5-13CDEP-2.5-16CDEP-2.8-10CDEP-2.8-11.5CDEP-2.8-13CDEP-2.8-16CDEP-3.2-10CDEP-3.2-11.5CDEP-3.2-13CDEP-3.2-16CDEP-3.2-6CDEP-3.2-8CDEP-3.65-10CDEP-3.65-11.5CDEP-3.65-13CDEP-3.65-16CDEP-3.65-6CDEP-3.65-8CDEP-4.5-10CDEP-4.5-11.5CDEP-4.5-13CDEP-4.5-16CDEP-4.5-6CDEP-4.5-8CDEP-5.4-10CDEP-5.4-11.5CDEP-5.4-13CDEP-5.4-6CDEP-5.4-8CDI-1.8-2.4CDI-2-3.2CDI-2.5-3.7CDI-2.7-4CDI-2.7-4.5CDI-3.1-5.5DE-2DE-2.5DE-2.8DE-3.2DE-3.65DE-4.2DE-5.2DELD-2DEP-2-16DEP-2.5-16DEP-2.8-16DEP-3.2-16DEP-3.65-16DEP-4.5-16DEP-5.4-16DI-2DI-2.5DI-2.8DI-3.2DI-3.65DI-4.2DI-5.2LD-2MDE-1.9MDI-1.9SDE-2SDE-2.5SDE-2.8SDE-3.2SDE-3.65SDE-4.2SDE-5.2SDI-2SDI-2.5SDI-2.8SDI-3.2SDI-3.65SDI-4.2SDI-5.2TB-3-4TB-4-5TB-5-6 | 2017 |
| Endosseous Dental Implant AccessoriesNDP · Class 1 | Implant instruments & surgical kits | Maker | — | 2017 |
| Intraoral Animal Source BarrierNPL · Class 2 | Bone grafts & membranes | Lister | Oral Matrix | 2025 |
Source: FDA establishment registration & device listing, 510(k) and product classification files · FDA data as of 2 Nov 2026 · snapshot 12 Nov 2026
510(k) clearances
Clearances on which FDA names Ritter Implants GmbH and Co. KG as the applicant, including filings under its other names.
| Decided | 510(k) | Device | Device type |
|---|---|---|---|
| 24 Jan 2019 | K180183 | Ritter Dental Implant System | DZE Root-Form Endosseous Implant |
| 14 Dec 2016 | K160475 | Ritter Dental Implant System | DZE Root-Form Endosseous Implant |
Some of these clearances are listed with FDA today by another company: Young Innovations Inc (1).
Also lists devices cleared under other names
Ritter Implants GmbH and Co. KG 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: Beijing Biosis Healing Biological Technology Co., Ltd (1), Ritter Implants GmbH CO KG (1).
| Decided | 510(k) | Device | Applicant | Device type |
|---|---|---|---|---|
| 16 Feb 2024 | K231513 | Oral Matrix | Beijing Biosis Healing Biological Technology Co., Ltd | NPL Intraoral Animal Source Barrier |
| 9 May 2014 | K131557 | RITTER IMPLANT SYSTEM | Ritter Implants GmbH CO KG | DZE Root-Form Endosseous Implant |
Registered establishments
| Establishment | Location | What it does |
|---|---|---|
| Ritter Implants GmbH & Co. KGFDA reg. 3009528809 | Biberach Baden-Wurttemberg, Germany | Manufacturer |
| SPFM, L.P.FDA reg. 3009506228 | San Antonio, TX, United States | Repacker / relabeler |
Other names on FDA records
SPFM, LP
Sources
FDA establishment registration & device listing (search FDA, owner/operator 10047159, 10039754). 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.