DeviceClearance

SWISSPLANT DENTAL IMPLANT SYSTEM— 510(k) K081396

Substantially Equivalent

Implant Direct, LLC

FDA 510(k) clearance K081396 for SWISSPLANT DENTAL IMPLANT SYSTEM, Substantially Equivalent on 2009-01-14. Applicant: Implant Direct, LLC.

Clearance details

Applicant
Implant Direct, LLC
Product code
Code NHA
Advisory panel
Dental
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
Calabasas, CA, US
Download summary PDFView on FDA.gov ↗

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.