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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Handpiece, Contra- And Right-Angle Attachment, Dental
510(k) Number K213139
Device Name SURGmatic S15 L Pro
Applicant
Kavo Dental GmbH
Bismarckring 39
Biberach,  DE 88400
Applicant Contact Kerstin Henseler
Correspondent
Kavo Dental GmbH
Bismarckring 39
Biberach,  DE 88400
Correspondent Contact Kerstin Henseler
Regulation Number872.4200
Classification Product Code
EGS  
Date Received09/27/2021
Decision Date 12/21/2021
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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