SPI TITANIUM BASE FOR CAD/CAM— 510(k) K102804

Name: FDA 510(k) clearance K102804
Creator: U.S. Food and Drug Administration
Published: 2011-04-20

Substantially Equivalent

Thommen Medical AG

FDA 510(k) clearance K102804 for SPI TITANIUM BASE FOR CAD/CAM, Substantially Equivalent on 2011-04-20. Applicant: Thommen Medical AG. Device class: 2.

Clearance details

Applicant: Thommen Medical AG
Product code: Code NHA
Device class: Class 2
Regulation: 21 CFR 872.3630
Advisory panel: Dental
Date received: 2010-09-27
Decision date: 2011-04-20
Decision: Substantially Equivalent
Clearance type: Traditional
Location: San Diego, CA, US

Download summary PDF View on FDA.gov ↗

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Adverse events under product code NHA

product code NHA

Injury: 1,270
Malfunction: 2,860
Total: 4,130

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. 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.