T2— 510(k) K212303

Substantially Equivalent

Osstem Implant Co., Ltd.

FDA 510(k) clearance K212303 for T2, Substantially Equivalent on 2021-09-21. Applicant: Osstem Implant Co., Ltd.. Device class: 2.

Clearance details

Applicant: Osstem Implant Co., Ltd.
Product code: Code OAS
Device class: Class 2
Regulation: 21 CFR 892.1750
Advisory panel: Radiology
Date received: 2021-07-23
Decision date: 2021-09-21
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Siheung-Si, KR

Download summary PDF View on FDA.gov ↗

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More clearances from Osstem Implant Co., Ltd.

K251434 — Healing Abutment System2026-03-04
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K233194 — TS Abutment System2024-02-20

Recalls naming K212303

K-number listed on FDA's recall record

Z-0314-2026 — Osstem Dental X-Ray System T2. Product Model Numbers T2-C and T2-CS.Class II·Ongoing·OSSTEM Implant Co., Ltd.·20250826

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K212303.

Data sourced from openFDA. This site is unofficial and independent of the FDA.