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510(k) K214084

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 20, 2022
Date Received
December 27, 2021
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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  • 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)
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Other clearances for product code OAS

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  • 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)