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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 K190003
Device Name Vivid Aligners
Orthodent Laboratory, Inc.
6325 Sheridan Drive
Buffalo,  NY  14221
Applicant Contact Michael Wright
Compliance Systems International, LLC.
1083 Delaware Ave.
Buffalo,  NY  14209
Correspondent Contact Robert O. Dean
Regulation Number872.5470
Classification Product Code
Date Received01/02/2019
Decision Date 11/06/2019
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No