CORE 3D ABUTMENT SYSTEM FOR DIGITAL PROSTHETIC SOLUTIONS— 510(k) K122295

Substantially Equivalent

Core 3D Protech, S.L.

FDA 510(k) clearance K122295 for CORE 3D ABUTMENT SYSTEM FOR DIGITAL PROSTHETIC SOLUTIONS, Substantially Equivalent on 2013-10-24. Applicant: Core 3D Protech, S.L..

Clearance details

Applicant: Core 3D Protech, S.L.
Product code: Code NHA
Advisory panel: Dental
Date received: 2012-07-31
Decision date: 2013-10-24
Decision: Substantially Equivalent
Clearance type: Abbreviated
Location: Santpedor, ES

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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.