PNP — Dental Abutment Design Software For Dental Laboratory Class II
Classification Details
- Product Code
- PNP
- Device Class
- Class II
- Regulation Number
- 872.3630
- Submission Type
- Review Panel
- DE
- Medical Specialty
- Dental
- Implant
- Yes
Definition
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.
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K233252 | institut straumann | Straumann CARES Visual and Nova Dental CAD | December 26, 2024 |
| K231529 | prismatik dentalcraft | CloudPoint FastDesign Chairside | March 14, 2024 |
| K221107 | rgorithm korea | TRUST | July 18, 2023 |
| K193352 | exocad | AbutmentCAD | July 21, 2021 |
| K200100 | 3shape | Abutment Design | October 7, 2020 |
| K200191 | dentsply sirona | Sirona Dental CAD/CAM System with InLab Software | August 19, 2020 |
| K181932 | nobel biocare | DTX Studio design | March 1, 2019 |
| K151455 | 3shape | 3Shape Abutment Designer Software | September 6, 2016 |