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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 K201104
Device Name AsoAligner
Aso International Manila, Inc.
Atlantica Bldg. 5, Block 12, Phase 1, South Avenue,
Cavite Economic Zone
Cavite,  PH 4106
Applicant Contact Hiromichi Takahashi
Emergo Global Consulting, LLC
2500 Bee Cave Road, Building 1, Suite 300
Austin,  TX  78746
Correspondent Contact Giselle Zhang
Regulation Number872.5470
Classification Product Code
Date Received04/24/2020
Decision Date 02/26/2021
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No