Home / 510(k) Clearances / K233252

510(k) K233252

Straumann CARES Visual and Nova Dental CAD by Institut Straumann AG — Product Code PNP

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 26, 2024
Date Received
September 28, 2023
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 Institut Straumann AG

  • K252168 — Straumann® BLC Implants - Indication Widening (March 10, 2026)
  • K253315 — Straumann Variobase Abutments XC for Bridge/Bar (January 22, 2026)
  • K250294 — Straumann® RidgeFit Implants (August 12, 2025)
  • K243278 — Custom Abutments (February 21, 2025)
  • K243478 — Straumann InLab Validated Workflow (February 19, 2025)
  • K241391 — Straumann® PURE Ceramic Implants (December 10, 2024)
  • K234049 — Straumann® BLC and TLC Implants - Line extension (March 20, 2024)
  • K230108 — Straumann® BLC and TLC Implants (September 14, 2023)
  • K223083 — Straumann SLActive labeling changes (June 22, 2023)
  • K222836 — Straumann® Variobase® Abutments and Straumann® n!ce® Zirconia discs (May 15, 2023)

Other clearances for product code PNP

  • K231529 — CloudPoint FastDesign Chairside (March 14, 2024)
  • K221107 — TRUST (July 18, 2023)
  • K193352 — AbutmentCAD (July 21, 2021)
  • K200100 — Abutment Design (October 7, 2020)
  • K200191 — Sirona Dental CAD/CAM System with InLab Software (August 19, 2020)
  • K181932 — DTX Studio design (March 1, 2019)
  • K151455 — 3Shape Abutment Designer Software (September 6, 2016)