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U.S. Department of Health and Human Services

Establishment Registration & Device Listing
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Proprietary Name: 3D Scanner D1000; 3D Scanner D2000; 3D scanner D500; 3D Scanner D700; 3D scanner D710; 3D Scanner D750; 3D Scanner D800; 3D Scanner D810; 3D Scanner D850; 3D scanner D900; 3D scanner D900L; 3D Scanner R1000; 3D Scanner R2000; 3D scanner R500; 3D Scanner R700; 3D scanner R710; 3D Scanner R750; 3D Scanner R850; 3D scanner R900; 3Shape Anatomy Design; 3Shape Dental System; 3Shape F8; Automate; E1 scanner; E2 Scanner; E3 Scanner; E4 Scanner; Novux D2000; Novux D750; Novux D850; Novux E1 Scanner; Novux E2 Scanner; Novux E3 Scanner; Novux E4 Scanner; Puffin; S1P-2 scanning tip; Trios 3; TRIOS 3 Wireles; TRIOS 4; Trios 6; Trios Interoral Dental System; Trios Move Pro; Trios Move+; TRIOS Patient Monitoring; TRIOS Scanner
Classification Name: SYSTEM, OPTICAL IMPRESSION, COMPUTER ASSISTED DESIGN AND MANUFACTURING (CAD/CAM) OF DENTAL RESTORATIONS
Product Code: NOF
Device Class: 2
Regulation Number: 872.3661
Medical Specialty: Dental
Registered Establishment Name: 3Shape Inc.
Registered Establishment Number: 3015193486
Owner/Operator: 3Shape A/S
Owner/Operator Number: 10023901
Establishment Operations: Contract Manufacturer
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