Browse hierarchy: [Dental (DE)](/submissions/DE) → [Subpart D — Prosthetic Devices](/submissions/DE/subpart-d%E2%80%94prosthetic-devices) → [21 CFR 872.3630](/submissions/DE/subpart-d%E2%80%94prosthetic-devices/872.3630) → PNP — Dental Abutment Design Software For Dental Laboratory

# PNP · Dental Abutment Design Software For Dental Laboratory

_Dental · 21 CFR 872.3630 · Class 2_

**Canonical URL:** https://fda.innolitics.com/submissions/DE/subpart-d%E2%80%94prosthetic-devices/PNP

## Overview

- **Product Code:** PNP
- **Device Name:** Dental Abutment Design Software For Dental Laboratory
- **Regulation:** [21 CFR 872.3630](/submissions/DE/subpart-d%E2%80%94prosthetic-devices/872.3630)
- **Device Class:** 2
- **Review Panel:** [Dental](/submissions/DE)
- **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](https://fda.innolitics.com/submissions/DE/subpart-d%E2%80%94prosthetic-devices/PNP/K233252.md) | Straumann CARES Visual and Nova Dental CAD | Institut Straumann AG | Dec 26, 2024 | SESE |
| [K231529](https://fda.innolitics.com/submissions/DE/subpart-d%E2%80%94prosthetic-devices/PNP/K231529.md) | CloudPoint FastDesign Chairside | Prismatik Dentalcraft, Inc. | Mar 14, 2024 | SESE |
| [K221107](https://fda.innolitics.com/submissions/DE/subpart-d%E2%80%94prosthetic-devices/PNP/K221107.md) | TRUST | Rgorithm Korea | Jul 18, 2023 | SESE |
| [K193352](https://fda.innolitics.com/submissions/DE/subpart-d%E2%80%94prosthetic-devices/PNP/K193352.md) | AbutmentCAD | Exocad GmbH | Jul 21, 2021 | SESE |
| [K200100](https://fda.innolitics.com/submissions/DE/subpart-d%E2%80%94prosthetic-devices/PNP/K200100.md) | Abutment Design | 3Shape A/S | Oct 7, 2020 | SESE |
| [K200191](https://fda.innolitics.com/submissions/DE/subpart-d%E2%80%94prosthetic-devices/PNP/K200191.md) | Sirona Dental CAD/CAM System with InLab Software | Dentsply Sirona | Aug 19, 2020 | SESE |
| [K181932](https://fda.innolitics.com/submissions/DE/subpart-d%E2%80%94prosthetic-devices/PNP/K181932.md) | DTX Studio design | Nobel Biocare AB | Mar 1, 2019 | SESE |
| [K151455](https://fda.innolitics.com/submissions/DE/subpart-d%E2%80%94prosthetic-devices/PNP/K151455.md) | 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

---

**Source:** [https://fda.innolitics.com/submissions/DE/subpart-d%E2%80%94prosthetic-devices/PNP](https://fda.innolitics.com/submissions/DE/subpart-d%E2%80%94prosthetic-devices/PNP)

**Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices. If you're preparing [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/), [get in touch](https://innolitics.com/contact).

**Cite:** Innolitics at https://innolitics.com