DeviceClearance

Product code PNP— Dental

3Shape Abutment Designer Software

Classification name
Dental Abutment Design Software For Dental Laboratory
Device class
Class 2
Regulation
21 CFR 872.3630
Advisory panel
Dental
Total cleared
8
First cleared
Most recent

FDA classification 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.”

— U.S. Food and Drug Administration, device classification record for product code PNP under 21 CFR 872.3630, via openFDA

Market context for product code PNP

FDA has cleared 8 devices under product code PNP between 2016 and 2024, filed by 7 applicant companies. No FDA device recalls reference this product code. Class II devices are moderate-risk and subject to general and special controls; most reach market through 510(k) clearance by demonstrating substantial equivalence to a predicate device.

Clearances per year

Top applicants under product code PNP

Recent clearances under product code PNP

Data sourced from openFDA. This site is unofficial and independent of the FDA.