Dental Abutment Design Software For Dental Laboratory
The Dental Abutment Design Software For Dental Laboratory (product code PNP) is a Class 2 dental device intended to aid in the restoration of chewing function by enabling a dental laboratory or dental clinician to design and fabricate the patient-specific component of a dental abutment, regulated under 872.3630. It requires 510(k) clearance and is flagged as an implant because the resulting abutment component is implanted as part of a dental implant system. The abutment-to-implant interface connection platform is not a patient-specific component.
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Basic Information
- Product Code
- PNP
- Device Class
- FDA class 2
- Regulation Number
- 872.3630
- Medical Specialty
- Dental
- Review Panel
- DE
- Submission Type
- 1
Device Characteristics
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.
510(k) Clearance History
Related 510(k) Clearances
This FDA classification is associated with 8 510(k) clearances via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K233252 | Straumann CARES Visual and Nova Dental CAD | Dec 26, 2024 | Substantially Equivalent | Institut Straumann AG |
| K231529 | CloudPoint FastDesign Chairside | Mar 14, 2024 | Substantially Equivalent | Prismatik Dentalcraft, Inc. |
| K221107 | TRUST | Jul 18, 2023 | Substantially Equivalent | Rgorithm Korea |
| K193352 | AbutmentCAD | Jul 21, 2021 | Substantially Equivalent | Exocad GmbH |
| K200100 | Abutment Design | Oct 07, 2020 | Substantially Equivalent | 3Shape A/S |
| K200191 | Sirona Dental CAD/CAM System with InLab Software | Aug 19, 2020 | Substantially Equivalent | Dentsply Sirona |
| K181932 | DTX Studio design | Mar 01, 2019 | Substantially Equivalent | Nobel Biocare AB |
| K151455 | 3Shape Abutment Designer Software | Sep 06, 2016 | Substantially Equivalent | 3Shape A/S |
FEI Numbers
This FDA classification entry is associated with 57 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 57 registration numbers. Click on an entry to view related FDA registrations.