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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 K252731
Device Name Promimic ZrP Surface Dental Implant; Promimic ZrP + HAnano Surface Dental Implant
Applicant
Promimic AB
Entreprenörsstråket 10
Mölndal,  SE 43153
Applicant Contact Oscar Davidsson
Correspondent
Promimic AB
Entreprenörsstråket 10
Mölndal,  SE 43153
Correspondent Contact Oscar Davidsson
Regulation Number872.3640
Classification Product Code
DZE  
Date Received08/28/2025
Decision Date 05/12/2026
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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