FDA product code PNP: Dental Abutment Design Software For Dental Laboratory
PNP is the FDA product code for dental abutment design software for dental laboratory. It is a Class II device, regulated under 21 CFR 872.3630 and reviewed by the Dental panel. FDA has cleared 8 510(k) submissions under PNP, 3 in the last five years, from 7 different applicants. The average 510(k) review took 370 days (median 374); 374 days on average over the last three years.
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.
Classification
| Field | Value |
|---|---|
| Device name | Dental Abutment Design Software For Dental Laboratory |
| Device class | Class II |
| Regulation | 21 CFR 872.3630 |
| Review panel | DE — Dental |
| Medical specialty | Dental |
| Premarket route | 510(k) |
| Implant | Yes |
510(k) clearances per year for PNP
| Year | Clearances | Avg. review days |
|---|---|---|
| 2019 | 1 | 225 |
| 2020 | 2 | 235 |
| 2021 | 1 | 595 |
| 2023 | 1 | 459 |
| 2024 | 2 | 374 |
Compare with all 510(k) review times · Search every PNP clearance
Top PNP applicants
| Applicant | Clearances | Latest |
|---|---|---|
| 3Shape A/S | 2 | 2020-10-07 |
| Institut Straumann AG | 1 | 2024-12-26 |
| Prismatik Dentalcraft, Inc. | 1 | 2024-03-14 |
| Rgorithm Korea | 1 | 2023-07-18 |
| Exocad GmbH | 1 | 2021-07-21 |
2 more applicants have PNP clearances. See the full list in Caduvo.
Most recent PNP clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K233252 | Institut Straumann AG | Straumann CARES Visual and Nova Dental CAD | 2024-12-26 | 455 |
| K231529 | Prismatik Dentalcraft, Inc. | CloudPoint FastDesign Chairside | 2024-03-14 | 293 |
| K221107 | Rgorithm Korea | TRUST | 2023-07-18 | 459 |
| K193352 | Exocad GmbH | AbutmentCAD | 2021-07-21 | 595 |
| K200100 | 3Shape A/S | Abutment Design | 2020-10-07 | 265 |
Recalls for PNP devices
openFDA lists no recalls for product code PNP.
Frequently asked questions
What is FDA product code PNP?
PNP is the FDA product code for dental abutment design software for dental laboratory. It is a Class II device, regulated under 21 CFR 872.3630 and reviewed by the Dental panel.
What device class is PNP?
Class II, regulation 21 CFR 872.3630. Typical premarket route: 510(k).
How long does a 510(k) take for product code PNP?
Across 8 cleared submissions the average was 370 days from receipt to decision (median 374).
Which companies have the most PNP clearances?
3Shape A/S (2); Institut Straumann AG (1); Prismatik Dentalcraft, Inc. (1); Rgorithm Korea (1); Exocad GmbH (1).
Next steps
- Run an FDA pathway report with predicate devices for product code PNP
- Run a recall and safety report across every PNP manufacturer
- Watch product code PNP for new clearances and recalls
Source: openFDA device classification, 510(k), PMA, De Novo and recall data (public domain). Review days run from FDA receipt to decision. Not regulatory advice.
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