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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 K191222
Device Name Inclusive Titanium Abutments compatible with: Dentsply Implants Astra Tech Implant System EV
Applicant
Prismatik Dentalcraft, Inc.
2212 Dupont Drive, Suite P
irvine,  CA  92612
Applicant Contact herbert schoenhoefer
Correspondent
PaxMed International, LLC
12264 El Camino Real, Suite 400
san diego,  CA  92130
Correspondent Contact kevin a. thomas
Regulation Number872.3630
Classification Product Code
NHA  
Date Received05/07/2019
Decision Date 08/05/2019
Decision substantially equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
summary summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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