P.004 NC CARES TITANIUM AND CERAMIC ABUTMENTS— 510(k) K081005
Substantially EquivalentInstitut Straumann AG
FDA 510(k) clearance K081005 for P.004 NC CARES TITANIUM AND CERAMIC ABUTMENTS, Substantially Equivalent on 2008-05-02. Applicant: Institut Straumann AG.
Clearance details
- Applicant
- Institut Straumann AG
- 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.