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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Implant, Endosseous, Root-Form
510(k) Number K242217
Device Name Surcam Dental Implant System
Applicant
Surcam Medical Devices and Developments, Ltd.
1 Hayotzrim
Nahariya,  IL 2231101
Applicant Contact Shay Shabat
Correspondent
Blackwell Device Consulting
P.O. Box 718
Gresham,  OR  97030
Correspondent Contact Angela Blackwell
Regulation Number872.3640
Classification Product Code
DZE  
Subsequent Product Code
NHA  
Date Received07/29/2024
Decision Date 01/29/2025
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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