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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Mouthguard, Prescription
510(k) Number K161884
Device Name Ortho System
Applicant
3Shape A/S
Holmens Kanal 7
Copenhagen,  DK 1060
Applicant Contact Hanne Nielsen
Correspondent
3Shape A/S
Holmens Kanal 7
Copenhagen,  DK 1060
Correspondent Contact Hanne Nielsen
Classification Product Code
MQC  
Date Received07/11/2016
Decision Date 04/19/2017
Decision Substantially Equivalent (SESE)
510k Review Panel Dental
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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