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U.S. Department of Health and Human Services

Product Classification

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Device dental abutment design software for dental laboratory
Regulation Description Endosseous dental implant abutment.
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.
Physical State Device is composed of software contained in a standard desktop computer, stand-alone computer unit, or online software, an intra- or extra-oral scanner, and a CAM unit.
Technical Method The device utilizes a digital image/impression of the patient's oral environment for the purpose of designing and creating a dental abutment. The device uses a validated CAM unit to create a physical version of the patient specific component of the dental abutment (i.e. abutment collar and abutment post). The abutment-to-implant interface/connection platform is not a patient-specific component of the dental abutment.
Target Area oral environment
Regulation Medical Specialty Dental
Review Panel Dental
Product CodePNP
Premarket Review Office of Device Evaluation (ODE)
Division of Anesthesiology, General Hospital, Infection Control, and Dental Devices (DAGRID)
Dental Devices Branch (DEDB)
Submission Type 510(k)
Regulation Number 872.3630
Device Class 2
Total Product Life Cycle (TPLC) TPLC Product Code Report
GMP Exempt? No
Implanted Device? Yes
Life-Sustain/Support Device? No
Third Party Review Not Third Party Eligible
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