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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Orthodontic Software
510(k) Number K181112
Device Name Orchestrate 3D
Applicant
Orchestrate 3D
1747 N. Riverside Ave.
Rialto,  CA  92376
Applicant Contact Todd Ehrler
Correspondent
Jcq Consulting
11218 Zest Ct. NE
Blaine,  MN  55449
Correspondent Contact Bill Jacqmein
Regulation Number872.5470
Classification Product Code
PNN  
Date Received04/27/2018
Decision Date 11/26/2018
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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