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U.S. Department of Health and Human Services

Establishment Registration & Device Listing
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Proprietary Name: Abutment designer
Classification Name: DENTAL ABUTMENT DESIGN SOFTWARE FOR DENTAL LABORATORY
Product Code: PNP
Device Class: 2
Regulation Number: 872.3630
Medical Specialty: Dental
Registered Establishment Name: 3shape inc
Registered Establishment Number: 3010728558
Premarket Submission Number: K151455
Owner/Operator: 3Shape A/S
Owner/Operator Number: 10023901
Establishment Operations: Complaint File Establishment
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