DENTAL IMPLANT COPING (PROSTHETIC ACCESSORIES TO THE ITI DENTAL IMPLANT SYSTEM)— 510(k) K032498
Substantially EquivalentStraumann USA
FDA 510(k) clearance K032498 for DENTAL IMPLANT COPING (PROSTHETIC ACCESSORIES TO THE ITI DENTAL IMPLANT SYSTEM), Substantially Equivalent on 2003-08-27. Applicant: Straumann USA.
Clearance details
- Applicant
- Straumann USA
- Product code
- Code NHA
- Advisory panel
- Dental
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Location
- Andover, MA, US
Adverse events under product code NHA
product code NHA- Injury
- 1,270
- Malfunction
- 2,860
- Total
- 4,130
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Data sourced from openFDA. This site is unofficial and independent of the FDA.