Not currently registered with FDA under this name
The Straumann Co.
Waltham, MA, United States. Named as applicant on 13 dental 510(k) clearances between 1992 and 2004. No establishment is registered with FDA under this exact name today.
- Device types listed
- 0
- Brands and models
- 0
- 510(k) clearances
- 131992–2004
- Markets registered in
- 1United States
- Establishments
- 0—
510(k) clearances per year, 1990–2026
510(k) clearances
Clearances on which FDA names The Straumann Co. as the applicant.
| Decided | 510(k) | Device | Device type |
|---|---|---|---|
| 23 Jul 2004 | K041070 | STRAUMANN TEMPORARY COPING | NHA Endosseous Dental Implant Abutment |
| 3 May 2004 | K040646 | STRAUMANN GRANULES | LYC Synthetic Bone Grafting Material |
| 30 Apr 2004 | K040469 | THE STRAUMANN ORTHO IMPLANT SYSTEM | OAT Orthodontic Endosseous Implant |
| 29 Dec 1999 | K993862 | MODUS SAGITTAL SPLIT PLATE | JEY Bone Plate |
| 15 Aug 1996 | K962023 | PLASTIC PROTECTION HEALING CAPS | DZE Root-Form Endosseous Implant |
| 18 Jun 1996 | K960634 | TITANIUM HEALING CAPS | DZE Root-Form Endosseous Implant |
| 15 Mar 1996 | K955281 | ENDOSSEOUS DENTAL IMPLANT & ACCESSORIES | DZE Root-Form Endosseous Implant |
| 23 Jan 1996 | K955369 | MEMFIX | DZL Intraosseous Fixation Screw |
| 14 Jun 1995 | K941393 | ITI ANGLED ABUTMENT | DZE Root-Form Endosseous Implant |
| 24 Mar 1995 | K943720 | ITI TRANSVERSAL SCREWING SYSTEM | DZE Root-Form Endosseous Implant |
| 26 Apr 1994 | K931993 | ITI DISTANCE SYSTEM | DZE Root-Form Endosseous Implant |
| 15 Jul 1992 | K920928 | PRE-STERILIZED ITI DENTAL IMPLANTS | DZE Root-Form Endosseous Implant |
| 21 Apr 1992 | K920768 | HOLLOW SCREW IMPLANTS 6MM, 14MM, 16MM | DZE Root-Form Endosseous Implant |
Some of these clearances are listed with FDA today by another company: Institut Straumann AG (6), Medartis AG (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.