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510(k) K221107

TRUST by Rgorithm Korea — Product Code PNP

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 18, 2023
Date Received
April 15, 2022
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Dental Abutment Design Software For Dental Laboratory
Device Class
Class II
Regulation Number
872.3630
Review Panel
DE
Submission Type

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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  • K151455 — 3Shape Abutment Designer Software (September 6, 2016)