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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 K221097
Device Name SmileSeries
Applicant
Ordont Orthodontic Laboratories, Inc.
1755 Smizer Station Rd.
Fenton,  MO  63026
Applicant Contact Paul Rudzicka
Correspondent
Trisler Consulting, Dba
7949 Beaumont Green E. Dr.
Indianapolis,  IN  46250
Correspondent Contact Patsy J Trisler
Regulation Number872.5470
Classification Product Code
NXC  
Date Received04/14/2022
Decision Date 07/14/2022
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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