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510(k) K193352

AbutmentCAD by Exocad GmbH — Product Code PNP

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 21, 2021
Date Received
December 4, 2019
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.

Other clearances by Exocad GmbH

  • K213302 — exoplan (May 3, 2022)
  • K183458 — exoplan 2.3 (August 6, 2019)

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  • K181932 — DTX Studio design (March 1, 2019)
  • K151455 — 3Shape Abutment Designer Software (September 6, 2016)