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Dental Abutment Design Software For Dental Laboratory

FDA product code PNP · 8 cleared devices

Class 2 Dental
Regulation
21 CFR 872.3630
Review panel
DE
Implant
Yes
Life sustaining
No
Third party review
No
GMP exempt
No
Clearance span
2016-09-06 – 2024-12-26

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.

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