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510(k) K133406

CS 8100 3D by Trophy — Product Code OAS

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 14, 2014
Date Received
November 6, 2013
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
X-Ray, Tomography, Computed, Dental
Device Class
Class II
Regulation Number
892.1750
Review Panel
RA
Submission Type

Produce cross-sectional diagnostic x-ray images of the intra-oral tissue and teeth.

Other clearances by Trophy

  • K193390 — CS Model+ (April 2, 2020)
  • K200183 — CS 9600 (March 13, 2020)
  • K181136 — CS 9600 (May 24, 2018)
  • K173622 — CS Imaging (January 16, 2018)
  • K151087 — CS 8100SC, CS8100SC Access (August 21, 2015)
  • K151837 — CS 3D Imaging (August 19, 2015)
  • K141607 — DENTAL IMAGING SOFTWARE (September 18, 2014)
  • K120975 — CS 8100 CS 8100 ACCESS (June 22, 2012)
  • K113419 — CS IMAGING (February 16, 2012)
  • K103659 — CS 9300, CS 9300C (August 18, 2011)

Other clearances for product code OAS

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  • K253959 — Primevision 3D (February 5, 2026)
  • K251798 — RCT700 (November 25, 2025)
  • K251842 — Dental Computed Tomography X-ray System (November 13, 2025)
  • K250060 — GT300; GT300-C (October 8, 2025)
  • K251642 — Dental CBCT X-ray System (June 27, 2025)
  • K243337 — Dental Cone Beam Computed Tomography System (April 17, 2025)
  • K243903 — RCT600 (March 12, 2025)
  • K243088 — Green X 12 SE (PHT-40CHS) (February 21, 2025)
  • K243081 — Green X 21 (PHT-90CHO) (February 14, 2025)