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 Nobel Biocare AB, Exocad GmbH and 3Shape A/S.

8
Total
8
Cleared
370d
Avg days
2016
Since
Declining activity - 1 submissions in the last 2 years vs 2 in the prior period
Review times increasing: avg 455d recently vs 358d historically

FDA 510(k) Cleared Dental Abutment Design Software For Dental Laboratory Devices (Product Code PNP)

8 devices
1–8 of 8
Cleared Dec 26, 2024
Straumann CARES Visual and Nova Dental CAD
K233252
Institut Straumann AG
Dental · 455d
Cleared Mar 14, 2024
CloudPoint FastDesign Chairside
K231529
Prismatik Dentalcraft, Inc.
Dental · 293d
Cleared Jul 18, 2023
TRUST
K221107
Rgorithm Korea
Dental · 459d
Cleared Jul 21, 2021
AbutmentCAD
K193352
Exocad GmbH
Dental · 595d
Cleared Oct 07, 2020
Abutment Design
K200100
3Shape A/S
Dental · 265d
Cleared Aug 19, 2020
Sirona Dental CAD/CAM System with InLab Software
K200191
Dentsply Sirona
Dental · 205d
Cleared Mar 01, 2019
DTX Studio design
K181932
Nobel Biocare AB
Dental · 225d

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 510(k) Review Time - PNP Product Code

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 →