Estar-Z— 510(k) K210097

Substantially Equivalent

Osstem Implant Co., Ltd.

FDA 510(k) clearance K210097 for Estar-Z, Substantially Equivalent on 2021-07-02. Applicant: Osstem Implant Co., Ltd.. Device class: 2.

Clearance details

Applicant: Osstem Implant Co., Ltd.
Product code: Code EIH
Device class: Class 2
Regulation: 21 CFR 872.6660
Advisory panel: Dental
Date received: 2021-01-14
Decision date: 2021-07-02
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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K242521 — Estar-ZE2024-11-20
K233806 — T2 Plus2024-09-06
K233194 — TS Abutment System2024-02-20

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