PNPClass II

Dental Abutment Design Software For Dental Laboratory

21 CFR 872.3630 / Dental

PNP is the FDA product code for Dental Abutment Design Software For Dental Laboratory, a class II device type, regulated under 21 CFR 872.3630. FDA's definition for this code reads: "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...". As of 2026-09-10, FDA records hold 8 510(k) clearances under this code, the most recent dated 2024-12-26, and no recalls.

Classification record

Product code: PNP
Device name: Dental Abutment Design Software For Dental Laboratory
FDA 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.
Regulation: 21 CFR 872.3630
Device class: Class II
Review panel: Dental
Submission type: 510(k)
Implant: Yes
Life sustaining or supporting: No
GMP exempt: No
Third party review eligible: No
Ingested clearances: 8
Ingested recalls: 0

Clearances, product code PNP

By decision year

8 clearances under product code PNP with a decision year between 2016 and 2024, 2020 the highest year at 2.

Show the numbers

510(k) clearances under FDA product code PNP by decision year
Year	Clearances
2016	1
2019	1
2020	2
2021	1
2023	1
2024	2

Applicants with the most clearances

Product code PNP

Applicants holding the most 510(k) clearances under product code PNP
Applicant	Clearances
3Shape A/S	2
Dentsply Sirona Inc	1
Exocad GmbH	1
Straumann USA, LLC	1
Nobel Biocare AB	1
Prismatik Dentalcraft, Inc.	1
Rgorithm Korea	1

Companies listing this code with FDA

Companies whose registered establishments list this code

12 of 50 companies shown, in name order

Recent clearances

Product code PNP

Recent recalls

Product code PNP

FDA records show no recalls under product code PNP.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device classification database, ingested from openFDA. The definition, regulation number, device class and review panel are FDA’s own fields, reproduced without editing.

MDM adds the counts: clearances by decision year, the applicants holding the most clearances under this code, recalls that name it, and the registered establishments that list it. Every count is computed from ingested records only.

Data as of 2026-10-05, the FDA export date for this dataset. Page last changed 2026-09-05. View this product code on fda.gov (opens on fda.gov)