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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
FOIA Releasable 510(k) K201104
Device Name AsoAligner
Applicant
Aso International Manila, Inc.
Atlantica Bldg. 5, Block 12, Phase 1, S. Ave.,
Cavite Economic Zone
Cavite,  PH 4106
Applicant Contact Hiromichi Takahashi
Correspondent
Emergo Global Consulting, LLC
2500 Bee Cave Rd.
Bldg. 1, Suite 300
Austin,  TX  78746
Correspondent Contact Giselle Zhang
Regulation Number872.5470
Classification Product Code
NXC  
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
Predetermined Change
Control Plan Authorized		 No
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