edelweiss CAD/CAM T-BLOCK +5 more— 510(k) K241131

Name: FDA 510(k) clearance K241131
Creator: U.S. Food and Drug Administration
Published: 2024-10-18

Substantially Equivalent

Edelweiss Dentistry Products GmbH

FDA 510(k) clearance K241131 for edelweiss CAD/CAM T-BLOCK +5 more, Substantially Equivalent on 2024-10-18. Applicant: Edelweiss Dentistry Products GmbH. Device class: 2.

Clearance details

Device name as filed: edelweiss CAD/CAM T-BLOCK; edelweiss CAD/CAM C-BLOCK; edelweiss CAD/CAM i-BLOCK; Ceramir CAD/CAM T-BLOCK; Ceramir CAD/CAM C-BLOCK; Ceramir CAD/CAM i-BLOCK
Applicant: Edelweiss Dentistry Products GmbH
Product code: Code EBF
Device class: Class 2
Regulation: 21 CFR 872.3690
Advisory panel: Dental
Date received: 2024-04-24
Decision date: 2024-10-18
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Wolfurt, AT

Download summary PDF View on FDA.gov ↗

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Data sourced from openFDA. This site is unofficial and independent of the FDA.