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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 K211510
Device Name uLab Systems Dental Aligner Kit
Applicant
uLab Systems, Inc.
1820 Gateway Drive, Suite 300
San Mateo,  CA  94404
Applicant Contact Amir Albolfathi
Correspondent
Sylvia Erickson Consulting
157 Ruby Avenue
San Carlos,  CA  94070
Correspondent Contact Sylvia Erickson
Regulation Number872.5470
Classification Product Code
NXC  
Date Received05/14/2021
Decision Date 02/24/2022
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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