Not currently registered with FDA under this name
Sulzer Dental, Inc.
Carlsbad, CA, United States. Named as applicant on 9 dental 510(k) clearances between 2001 and 2002. No establishment is registered with FDA under this exact name today.
- Device types listed
- 0
- Brands and models
- 0
- 510(k) clearances
- 92001–2002
- Markets registered in
- 27 registrations outside the US
- Establishments
- 0—
510(k) clearances per year, 2000–2026
Registered in 2 markets
Where regulators' registries name Sulzer Dental, Inc. 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 | Sulzer Dental, Inc. | 9 clearances | 2001–2002 | Below |
| South Korea | MFDS | Manufacturer | Sulzer Dental IncSulzer Dental Inc. | 7 | 1999–2002 | 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 Sulzer Dental, Inc. as the applicant.
| Decided | 510(k) | Device | Device type |
|---|---|---|---|
| 13 Nov 2002 | K014050 | HEX-LOCK TEMPORARY ABUTMENT | DZE Root-Form Endosseous Implant |
| 20 Mar 2002 | K014175 | SULZER DENTAL CERAMIC SYSTEM-HEXLOCK | NHA Endosseous Dental Implant Abutment |
| 19 Mar 2002 | K014214 | SULZER DENTAL CERAMIC SYSTEM-SPLINE | DZE Root-Form Endosseous Implant |
| 18 Jan 2002 | K013494 | 3.75MM AND 5.0MM SPLINE TWIST IMPLANT | DZE Root-Form Endosseous Implant |
| 19 Nov 2001 | K013227 | SCREW VENT IMPLANT; TAPERED SCREW VENT IMPLANT | DZE Root-Form Endosseous Implant |
| 6 Sep 2001 | K012055 | 3.25MM SPLINE TWIST IMPLANT | DZE Root-Form Endosseous Implant |
| 25 Jun 2001 | K011245 | ADVENT IMPLANT SYSTEM, SWISS PLUS IMPLANT SYSTEM | DZE Root-Form Endosseous Implant |
| 21 May 2001 | K011028 | SCREW-VENT DENTAL IMPLANT SYSTEM | DZE Root-Form Endosseous Implant |
| 15 May 2001 | K011038 | TAPER-LOCK DENTAL IMPLANT SYSTEM | DZE Root-Form Endosseous Implant |
Some of these clearances are listed with FDA today by another company: ZimVie US Corp LLC (6), ARCH Medical Solutions - Escondido LLC (2), Digital Age Dental Laboratories, Ltd. (1).
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.