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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 K251938
Device Name GEN5 and GEN5+ Dental Implant System
Applicant
Paragon Implant Mfg., LLC
27030 Malibu Hills Rd.
Calabasas,  CA  91301
Applicant Contact Renee Bennett
Correspondent
Paragon Implant Mfg., LLC
27030 Malibu Hills Rd.
Calabasas,  CA  91301
Correspondent Contact Renee Bennett
Regulation Number872.3640
Classification Product Code
DZE  
Subsequent Product Code
NHA  
Date Received06/24/2025
Decision Date 10/30/2025
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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