Straumann CARES M-Series CAD/CAM System— 510(k) K203456

Substantially Equivalent

Institut Straumann AG

FDA 510(k) clearance K203456 for Straumann CARES M-Series CAD/CAM System, Substantially Equivalent on 2021-06-23. Applicant: Institut Straumann AG.

Clearance details

Applicant: Institut Straumann AG
Product code: Code NHA
Advisory panel: Dental
Date received: 2020-11-23
Decision date: 2021-06-23
Decision: Substantially Equivalent
Clearance type: Special
Location: Basel, CH

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.