Dental Abutment Design Software For Dental Laboratory
PNP · Class II — Moderate Risk (510(k) clearance required) · Dental · 21 CFR 872.3630
Classification
FDA Product Code
PNP
Device class
Class II — Moderate Risk (510(k) clearance required)
Regulation
21 CFR 872.3630
Review panel
DE
Medical specialty
Dental
Submission type
1
GMP exempt
N
Life sustaining
N
Implant
Y
Third-party review
N
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.