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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 K240143
Device Name JDZygoma dental implants
Applicant
Jdentalcare Srl
Via Dino Campana, 2
Modena,  IT 41103
Applicant Contact Grandi Antonio
Correspondent
Maurizio Pantaleoni
Via Borgo Santa Cristina 12
Imoa,  IT 40026
Correspondent Contact Pantaleoni Maurizio
Regulation Number872.3640
Classification Product Code
DZE  
Subsequent Product Code
NHA  
Date Received01/18/2024
Decision Date 10/11/2024
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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