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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name Abutment, Implant, Dental, Endosseous
510(k) Number K231132
Device Name J & P Click Attachments
Applicant
J & P Dental Technologies
1309 S Adams St
Fort Worth,  TX  76104
Applicant Contact Babak Aaron Paz
Correspondent
Blackwell Device Consulting
P.O. Box 718
Gresham,  OR  97030 -0172
Correspondent Contact Angela Blackwell
Regulation Number872.3630
Classification Product Code
NHA  
Date Received04/21/2023
Decision Date 03/26/2024
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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