AMERICAN DENTAL IMPLANT ABUTMENT SYSTEM— 510(k) K080397
Substantially EquivalentAmerican Dental Implant Corporation
FDA 510(k) clearance K080397 for AMERICAN DENTAL IMPLANT ABUTMENT SYSTEM, Substantially Equivalent on 2008-05-06. Applicant: American Dental Implant Corporation.
Clearance details
- Applicant
- American Dental Implant Corporation
- Product code
- Code NHA
- Advisory panel
- Dental
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- New Castle, PA, 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.