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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
Applicant
Ortho Caps GmbH
An Der Bewer 8
Hamm 59069,  DE
Applicant Contact Wajeeh Khan
Correspondent
Rmo, Inc.
650 W. Colfax Ave.
Denver,  CO  80204
Correspondent Contact Angelica Ayala
Regulation Number872.5470
Classification Product Code
NXC  
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
Predetermined Change
Control Plan Authorized		 No
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