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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 K182826
Device Name Ormco Spark Aligner System
Applicant
Sybron Dental Specialties
1717 W. Collins Ave.
Orange,  CA  92687
Applicant Contact Mey Saied
Correspondent
REGULATORY TECHNOLOGY SERVICES, LLC
1000 Westgate Drive,
Suite 510k
Saint Paul,  MN  55114
Correspondent Contact Mark Job
Regulation Number872.5470
Classification Product Code
NXC  
Date Received10/05/2018
Decision Date 10/11/2018
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
Summary Summary
Type Traditional
Reviewed by Third Party Yes
Combination Product No
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