STRAUMANN COMPUTER AIDED RESTORATION SERVICE— 510(k) K052272

Substantially Equivalent

Straumann USA

FDA 510(k) clearance K052272 for STRAUMANN COMPUTER AIDED RESTORATION SERVICE, Substantially Equivalent on 2006-01-03. Applicant: Straumann USA.

Clearance details

Applicant: Straumann USA
Product code: Code NHA
Advisory panel: Dental
Date received: 2005-08-22
Decision date: 2006-01-03
Decision: Substantially Equivalent
Clearance type: Special
Location: Andover, MA, US

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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.