Not currently registered with FDA under this name
Friadent GmbH
Lake Forest, CA, United States. Named as applicant on 18 dental 510(k) clearances between 1999 and 2004. No establishment is registered with FDA under this exact name today.
- Device types listed
- 0
- Brands and models
- 0
- 510(k) clearances
- 181999–2004
- Markets registered in
- 342 registrations outside the US
- Establishments
- 0—
510(k) clearances per year, 1990–2026
Registered in 3 markets
Where regulators' registries name Friadent 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 | Applicant | Friadent GmbH | 18 clearances | 1999–2004 | Below |
| South Korea | MFDS | Manufacturer | FRIADENT GmbHFriadent GmbH | 38 | 1999–2006 | Pure Global AI |
| Hong Kong | MDD | Manufacturer | Friadent GmbH | 4 | 2009–2009 | 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
510(k) clearances
Clearances on which FDA names Friadent GmbH as the applicant.
| Decided | 510(k) | Device | Device type |
|---|---|---|---|
| 27 Oct 2004 | K040170 | FRIADENT PLUS DENTAL IMPLANT SYSTEMS | DZE Root-Form Endosseous Implant |
| 26 Aug 2004 | K041509 | ANKYLOS DENTAL IMPLANT SYSTEM | DZE Root-Form Endosseous Implant |
| 1 Jul 2004 | K040946 | ANKYLOS DENTAL IMPLANT SYSTEM | DZE Root-Form Endosseous Implant |
| 2 Oct 2003 | K032302 | XIVE TG ABUTMENTS | DZE Root-Form Endosseous Implant |
| 14 Aug 2003 | K032284 | XIVE TG DENTAL IMPLANT SYSTEM | DZE Root-Form Endosseous Implant |
| 14 Aug 2003 | K032158 | XIVE DENTAL IMPLANT SYSTEM MULTIPLE | DZE Root-Form Endosseous Implant |
| 14 Aug 2003 | K031674 | MODIFICATION TO FRIALIT-2 DENTAL IMPLANT SYSTEM | DZE Root-Form Endosseous Implant |
| 3 Mar 2003 | K024004 | XIVE TRANSGINGIVAL DENTAL IMPLANT SYSTEM | DZE Root-Form Endosseous Implant |
| 5 Feb 2003 | K023799 | FRIOS ALGIPORE | LYC Synthetic Bone Grafting Material |
| 2 Jul 2002 | K021318 | XIVE DENTAL IMPLANT SYSTEM | DZE Root-Form Endosseous Implant |
| 9 Apr 2002 | K013067 | FRIALOC DENTAL IMPLANT SYSTEM | DZE Root-Form Endosseous Implant |
| 15 Mar 2002 | K013867 | XIVE DENTAL IMPLANT SYSTEM | DZE Root-Form Endosseous Implant |
| 20 Dec 2001 | K013438 | FRIALIT-2 ESTHETICBASE ABUTMENT | DZE Root-Form Endosseous Implant |
| 20 Apr 2000 | K994174 | FRIALIT-2 MH-2 ABUTMENT | DZE Root-Form Endosseous Implant |
| 24 Mar 2000 | K994376 | FRIALIT-2 3.4MM STEEPED CYLINDER IMPLANT WITH FRIOS TPS COATING; FRIALIT-2 3.4MM STEEPED CYLINDER IMPLANT WITH FRIOS HA | DZE Root-Form Endosseous Implant |
| 18 Feb 2000 | K994298 | FRIOS MICROSAW | KMW Rotary Bone Cutting Handpiece |
| 10 Jan 2000 | K993560 | FRIALIT-2 BONE PROFILER | DZE Root-Form Endosseous Implant |
| 9 Dec 1999 | K993095 | FRIALIT-2 SELECT COMPONENTS | DZE Root-Form Endosseous Implant |
Some of these clearances are listed with FDA today by another company: Dentsply Sirona, Inc. (9).
Sources
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 of the most recent filing, which can be a US agent.