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U.S. Department of Health and Human Services

Establishment Registration & Device Listing
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Proprietary Name: 3Shape Ortho System
Classification Name: ORTHODONTIC SOFTWARE
Product Code: PNN
Device Class: 2
Regulation Number: 872.5470
Medical Specialty: Dental
Registered Establishment Name: 3Shape A/S
Registered Establishment Number: 3005940400
Premarket Submission Number: K152086
Owner/Operator: 3Shape A/S
Owner/Operator Number: 10023901
Establishment Operations: Manufacturer
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