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U.S. Department of Health and Human Services

Establishment Registration & Device Listing
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Proprietary Name: Trios 5 (L1P-1F)
Classification Name: LASER, FLUORESCENCE CARIES DETECTION
Product Code: NBL
Device Class: 2
Regulation Number: 872.1745
Medical Specialty: Dental
Registered Establishment Name: 3Shape Inc.
Registered Establishment Number: 3015193486
Premarket Submission Number: K242103
Owner/Operator: 3Shape A/S
Owner/Operator Number: 10023901
Establishment Operations: Contract Manufacturer
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