T2

FDA 510(k) K212303 · Osstem Implant Co., Ltd.

Substantially Equivalent

510(k) numberK212303

Submission

Device name
T2
Applicant
Osstem Implant Co., Ltd.
Siheung-Si, KR
Received
July 23, 2021
Decision date
September 21, 2021
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) summary available from FDA

Official FDA 510(k) record

Device classification

Product code
OAS – X-Ray, Tomography, Computed, Dental
Device class
Class II (moderate risk)
Regulation
21 CFR 892.1750
Specialty
Radiology

Produce cross-sectional diagnostic x-ray images of the intra-oral tissue and teeth.

Other 510(k)s with product code OAS

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K260662Dental Cone Beam Computed Tomography SystemOAS · Special Yofo Medical Technology Co., Ltd.06/04/2026SE
K253935medXion NEXUSOAS · Traditional medXion Technologies, Inc.05/15/2026SE
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K260093Green X 12 VE (PHT-70CHS); Green X VE (PHT-70CHS)OAS · Special VATECH Co., Ltd.03/31/2026SE
K252353myray ProXIma X6OAS · Traditional Cefla S.C.03/10/2026SE
K253959Primevision 3DOAS · Traditional Dentsply Sirona02/05/2026SE
K251798RCT700OAS · Traditional Ray Co., Ltd.11/25/2025SE
K251842Dental Computed Tomography X-ray SystemOAS · Traditional Fussen Technology Co., Ltd.11/13/2025SE

More from Fussen Technology Co., Ltd.

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K233806T2 PlusOAS · Traditional 09/06/2024SE
K233194TS Abutment SystemNHA · Traditional 02/20/2024SE
K232220SS Abutment SystemNHA · Traditional 12/05/2023SE
K232012N1EHD · Traditional 11/28/2023SE
K222778Osstem Implant SystemDZE · Traditional 09/23/2023SE
K221684Osstem Abutment SystemNHA · Traditional 09/08/2022SE
K210097Estar-ZEIH · Traditional 07/02/2021SE

Questions and answers

When was T2 cleared by the FDA?

T2 (K212303) received a 510(k) decision of Substantially Equivalent on September 21, 2021, 60 days after the submission was received.

What is the product code of K212303?

The FDA product code is OAS – X-Ray, Tomography, Computed, Dental, a Class II (moderate risk) device regulated under 21 CFR 892.1750.