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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 K171860
Device Name Sureclear aligners
Applicant
Emergo Global Consulting, LLC
2500 Bee Cave Rd.
Bldg. 1, Suite 300
Austin,  TX  78746
Applicant Contact Stuart R. Goldman
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 Received06/22/2017
Decision Date 01/05/2018
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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