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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 K182388
Device Name Krystal Klear Aligners
Applicant
Shatkin F.I.R.S.T., LLC
2495 Kensington Ave.
Amherst,  NY  14226
Applicant Contact Kimberly Wiesmore
Correspondent
Shatkin F.I.R.S.T., LLC
2495 Kensington Ave.
Amherst,  NY  14226
Correspondent Contact Kimberly Wiesmore
Regulation Number872.5470
Classification Product Code
NXC  
Date Received09/04/2018
Decision Date 12/19/2019
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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