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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 K163689
FOIA Releasable 510(k) K163689
Device Name 3M Clear Tray Aligner
Applicant
3M Unitek Corporation
2724 S. Peck Rd.
Monrovia,  CA  91016
Applicant Contact Yanine Garcia-Quezada
Correspondent
Regulatory Technology Services, LLC
1000 Westgate Dr. Suite #510k
Saint Paul,  MN  55114
Correspondent Contact MARK JOB
Regulation Number872.5470
Classification Product Code
NXC  
Date Received12/28/2016
Decision Date 01/27/2017
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
Summary Summary
Type Traditional
Reviewed by Third Party Yes
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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