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510(k) K220392

PAPAYA 3D & PAPAYA 3D Plus by Genoray Co., Ltd. — Product Code OAS

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 19, 2022
Date Received
February 11, 2022
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 Genoray Co., Ltd.

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  • K232158 — GenX-CR (September 13, 2023)
  • K230787 — Oscar 15 & Oscar 15i (July 20, 2023)
  • K220423 — PAPAYA & PAPAYA Plus (May 19, 2022)
  • K211780 — ZEN-2090 Turbo (March 9, 2022)
  • K200469 — PAPAYA 3D Premium & PAPAYA 3D Premium Plus (September 16, 2020)
  • K181943 — OSCAR (OSCAR Prime, OSCAR Classic) (August 17, 2018)
  • K172810 — PORT-X IV (March 7, 2018)

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)