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510(k) K183475

T1-CS, T1-C by Osstem Implant Co., Ltd. — Product Code OAS

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 30, 2019
Date Received
December 17, 2018
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 Osstem Implant Co., Ltd.

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  • K233194 — TS Abutment System (February 20, 2024)
  • K232220 — SS Abutment System (December 5, 2023)
  • K232012 — N1 (November 28, 2023)
  • K222778 — Osstem Implant System (September 23, 2023)
  • K221684 — Osstem Abutment System (September 8, 2022)
  • K212303 — T2 (September 21, 2021)

Other clearances for product code OAS

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  • 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)