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510(k) K133406

CS 8100 3D by Trophy — Product Code OAS

K133406 is an FDA 510(k) premarket notification submitted by Trophy for the device "CS 8100 3D". The FDA issued a decision of Substantially Equivalent on March 14, 2014. The device falls under product code OAS (X-Ray, Tomography, Computed, Dental), a Class II device regulated under 21 CFR 892.1750. Trophy has at least 10 other 510(k) clearances on record.

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

  • K261748 — Dental Cone-beam Computed Tomography (mDX-15P Series) (July 23, 2026)
  • K250839 — Dental X-ray System (June 11, 2026)
  • K260662 — Dental Cone Beam Computed Tomography System (June 4, 2026)
  • K253935 — medXion NEXUS (May 15, 2026)
  • K260462 — RCT800 (April 9, 2026)
  • K260093 — Green X 12 VE (PHT-70CHS); Green X VE (PHT-70CHS) (March 31, 2026)
  • K252353 — myray ProXIma X6 (March 10, 2026)
  • K253959 — Primevision 3D (February 5, 2026)
  • K251798 — RCT700 (November 25, 2025)
  • K251842 — Dental Computed Tomography X-ray System (November 13, 2025)

FDA data resources