SPI CUSTOMIZABLE GINGIVA FORMER— 510(k) K092248

Substantially Equivalent

Thommen Medical AG

FDA 510(k) clearance K092248 for SPI CUSTOMIZABLE GINGIVA FORMER, Substantially Equivalent on 2009-09-25. Applicant: Thommen Medical AG.

Clearance details

Applicant: Thommen Medical AG
Product code: Code NHA
Advisory panel: Dental
Date received: 2009-07-28
Decision date: 2009-09-25
Decision: Substantially Equivalent
Clearance type: Special
Location: San Diego, CA, US

Download summary PDF View 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, 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.