DeviceClearance

SPI EASY 4.0 ABUTMENT— 510(k) K071453

Substantially Equivalent

Thommen Medical AG

FDA 510(k) clearance K071453 for SPI EASY 4.0 ABUTMENT, Substantially Equivalent on 2007-09-19. Applicant: Thommen Medical AG.

Clearance details

Applicant
Thommen Medical AG
Product code
Code NHA
Advisory panel
Dental
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Special
Location
San Diego, 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.