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U.S. Department of Health and Human Services

Establishment Registration & Device Listing
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Proprietary Name: Heron IOS; OVO 3; OVO IOS
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: 3D Imaging And Simulation Corp. Americas
Registered Establishment Number: 3008321355
Owner/Operator: 3DISC Americas
Owner/Operator Number: 10033930
Establishment Operations: Manufacturer
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