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510(k) K223794

hyperion X9 pro, NewTom GiANO HR, X-RADiUS TRiO PLUS by Cefla S.C. — Product Code OAS

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 17, 2023
Date Received
December 19, 2022
Clearance Type
Special
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.

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  • K213022 — CEFLA Dental Micromotors: i-MMr, i-MMr L, i-MMs, i-XR3, i-XR3 L, i-XS4, handy PO (May 9, 2022)
  • K220664 — NewTom 7G (May 6, 2022)
  • K214084 — hyperion X9 pro, NewTom GiANO HR, X-RADiUS TRiO PLUS (January 20, 2022)
  • K200688 — hyperion X5, NewTom GO, X-RADiUS COMPACT (April 9, 2020)
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  • K183448 — NewTom 5G XL (March 8, 2019)
  • K161848 — Family of Steam sterilizers B17 B22 Series (February 23, 2017)

Other clearances for product code OAS

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  • 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)