Not currently registered with FDA under this name
Sulzer Calcitek, Inc.
Carlsbad, CA, United States. Named as applicant on 9 dental 510(k) clearances between 1997 and 2001. No establishment is registered with FDA under this exact name today.
- Device types listed
- 0
- Brands and models
- 0
- 510(k) clearances
- 91997–2001
- Markets registered in
- 1United States
- Establishments
- 0—
510(k) clearances per year, 1990–2026
510(k) clearances
Clearances on which FDA names Sulzer Calcitek, Inc. as the applicant.
| Decided | 510(k) | Device | Device type |
|---|---|---|---|
| 19 Jan 2001 | K010073 | SPLINE DENTAL IMPLANT SYSTEM | DZE Root-Form Endosseous Implant |
| 21 Jun 2000 | K001786 | TEMPORARY GINGIVAL CUFF AND IMPRESSION POST AND IMPLANT ANALOG | DZE Root-Form Endosseous Implant |
| 16 Jun 1999 | K984536 | REMOVABLE CUFF ABUTMENT | DZE Root-Form Endosseous Implant |
| 22 Sep 1998 | K982305 | SPLINE DENTAL IMPLANT SYSTEM-TEMPORARY ABUTMENT | DZE Root-Form Endosseous Implant |
| 30 Jul 1998 | K981562 | SPLINE DENTAL IMPLANT SYSTEM - SPLINE XI IMPLANT | EBF Resin Tooth Shade Material |
| 20 Nov 1997 | K973521 | VARIABLE PARALLEL PIN | DZE Root-Form Endosseous Implant |
| 23 Jun 1997 | K970752 | SPLINE ENGAGING SHOULDERED ABUTMENT SYSTEM | DZE Root-Form Endosseous Implant |
| 23 Jun 1997 | K970127 | EDOSSEOUS DENTAL IMPLANT | DZE Root-Form Endosseous Implant |
| 25 Feb 1997 | K964768 | THREADLOC DENTAL IMPLANT SYSTEMS | DZE Root-Form Endosseous Implant |
Some of these clearances are listed with FDA today by another company: ZimVie US Corp LLC (4), ARCH Medical Solutions - Escondido LLC (2).
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.