PNP · Class II · 21 CFR 872.3630

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.

2
Total
2
Cleared
374d
Avg days
2024
Since

List of Dental Abutment Design Software For Dental Laboratory devices cleared through 510(k)

2 devices
1–2 of 2

How to use this database

This page lists all FDA 510(k) submissions for Dental Abutment Design Software For Dental Laboratory devices (product code PNP). Click any device to view full submission details, including the decision date, manufacturer information, predicate device, and a link to the official FDA record.

These devices fall under the Dental FDA review panel. Browse all Dental devices →