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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Material, Tooth Shade, Resin
510(k) Number K211345
Device Name C-30 Crown Kit
Applicant
Perfect Fit Crowns, LLC
1128 Royal Palm Beach Blvd., #166
Royal Palm Beach,  FL  33411
Applicant Contact Steve Ziskind
Correspondent
Evo820, LLC
1 Baya St.
Cairo,  CA  92694
Correspondent Contact Tim Torbenson
Regulation Number872.3690
Classification Product Code
EBF  
Subsequent Product Code
EMA  
Date Received05/03/2021
Decision Date 11/24/2021
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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