PNP · Dental Abutment Design Software For Dental Laboratory
Dental · 21 CFR 872.3630 · Class 2
Overview
| Product Code | PNP |
|---|---|
| Device Name | Dental Abutment Design Software For Dental Laboratory |
| Regulation | 21 CFR 872.3630 |
| Device Class | Class 2 |
| Review Panel | Dental |
| Implant | Yes |
Identification
An endosseous dental implant abutment is a premanufactured prosthetic component directly connected to the endosseous dental implant and is intended for use as an aid in prosthetic rehabilitation.
Classification Rationale
Class II (special controls). The guidance document entitled “Class II Special Controls Guidance Document: Root-Form Endosseous Dental Implants and Endosseous Dental Implant Abutments” will serve as the special control. (See § 872.1(e) for the availability of this guidance document.)
Special Controls
*Classification.* Class II (special controls). The guidance document entitled “Class II Special Controls Guidance Document: Root-Form Endosseous Dental Implants and Endosseous Dental Implant Abutments” will serve as the special control. (See § 872.1(e) for the availability of this guidance document.)
Recent Cleared Devices (8 of 8)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K233252 | Straumann CARES Visual and Nova Dental CAD | Institut Straumann AG | Dec 26, 2024 | SESE |
| K231529 | CloudPoint FastDesign Chairside | Prismatik Dentalcraft, Inc. | Mar 14, 2024 | SESE |
| K221107 | TRUST | Rgorithm Korea | Jul 18, 2023 | SESE |
| K193352 | AbutmentCAD | Exocad GmbH | Jul 21, 2021 | SESE |
| K200100 | Abutment Design | 3Shape A/S | Oct 7, 2020 | SESE |
| K200191 | Sirona Dental CAD/CAM System with InLab Software | Dentsply Sirona | Aug 19, 2020 | SESE |
| K181932 | DTX Studio design | Nobel Biocare AB | Mar 1, 2019 | SESE |
| K151455 | 3Shape Abutment Designer Software | 3Shape A/S | Sep 6, 2016 | SESE |
Top Applicants
- 3Shape A/S — 2 clearances
- Rgorithm Korea — 1 clearance
- Prismatik Dentalcraft, Inc. — 1 clearance
- Nobel Biocare AB — 1 clearance
- Institut Straumann AG — 1 clearance
