FDA Product Code PNP: Dental Abutment Design Software For Dental Laboratory
The Device Is Intended To Aid In The Restoration Of Chewing Function By Allowing A Dental Laboratory Or Dental Clinician To Design The Patient-specific Component Of A Dental Abutment (i.e. Abutment Collar And Abutment Post) And Cam Or Create That Component At A Dental Office Or Dental Laboratory Following The Directions Of The Dental Implant System. The Abutment-to-implant Interface/connection Platform Is Not A Patient-specific Component Of The Dental Abutment.
Leading manufacturers include Prismatik Dentalcraft, Inc. and Institut Straumann AG.
FDA 510(k) Cleared Dental Abutment Design Software For Dental Laboratory Devices (Product Code PNP)
About Product Code PNP - Regulatory Context
510(k) Submission Activity
8 total 510(k) submissions under product code PNP since 2016, with 8 receiving FDA clearance (average review time: 370 days).
Submission volume has declined in recent years - 1 submissions in the last 24 months compared to 2 in the prior period.
FDA Review Time
Recent submissions under PNP have taken an average of 455 days to reach a decision - up from 358 days historically. Manufacturers should account for longer review timelines in current project planning.
PNP devices are reviewed by the Dental panel. Browse all Dental devices →