Home / 510(k) Clearances / K212303

510(k) K212303

T2 by Osstem Implant Co., Ltd. — Product Code OAS

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 21, 2021
Date Received
July 23, 2021
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.

  • K251434 — Healing Abutment System (March 4, 2026)
  • K251569 — Bone Screw (August 13, 2025)
  • K242521 — Estar-ZE (November 20, 2024)
  • K233806 — T2 Plus (September 6, 2024)
  • 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)
  • K210097 — Estar-Z (July 2, 2021)

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)