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510(k) K123381

HYPERION X9 by Cefla S.C. — Product Code OAS

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 10, 2013
Date Received
November 1, 2012
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 Cefla S.C.

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  • K231990 — Apex Locator (February 13, 2024)
  • K223794 — hyperion X9 pro, NewTom GiANO HR, X-RADiUS TRiO PLUS (January 17, 2023)
  • 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)
  • K190496 — hyperion X9 pro, NewTom GiANO HR, X-RADiUS TRiO PLUS (April 24, 2019)
  • K183448 — NewTom 5G XL (March 8, 2019)

Other clearances for product code OAS

  • 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)
  • 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)