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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name aligner, sequential
510(k) Number K180241
Device Name Orthocaps Twinaligner
Ortho Caps GmbH
An der Bewer 8
Hamm 59069,  DE
Applicant Contact Wajeeh Khan
RMO, Inc.
650 W. Colfax Ave
Denver,  CO  80204
Correspondent Contact Angelica Ayala
Regulation Number872.5470
Classification Product Code
Date Received01/29/2018
Decision Date 09/28/2018
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No