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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Accessories, Implant, Dental, Endosseous
510(k) Number K190059
Device Name CEREC Guides
Applicant
Dentsply Sirona
221 West Philadelphia St., Suite 60W
York,  PA  17401
Applicant Contact Karl J. Nittinger
Correspondent
Dentsply Sirona
221 West Philadelphia St., Suite 60W
York,  PA  17401
Correspondent Contact Karl J. Nittinger
Regulation Number872.3980
Classification Product Code
NDP  
Date Received01/11/2019
Decision Date 09/27/2019
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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