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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 Mouthguard
Classification Name: MOUTHGUARD, PRESCRIPTION
Product Code: MQC
Device Class: Unclassified
Registered Establishment Name: 3Shape A/S
Registered Establishment Number: 3005940400
Premarket Submission Number: K161884
Owner/Operator: 3Shape A/S
Owner/Operator Number: 10023901
Establishment Operations: Specification Developer
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