E-CUBE— 510(k) K111616

Substantially Equivalent

Saeshin Precision Co., Ltd.

FDA 510(k) clearance K111616 for E-CUBE, Substantially Equivalent on 2011-08-19. Applicant: Saeshin Precision Co., Ltd.. Device class: 1.

Clearance details

Applicant: Saeshin Precision Co., Ltd.
Product code: Code EKX
Device class: Class 1
Regulation: 21 CFR 872.4200
Advisory panel: Dental
Date received: 2011-06-10
Decision date: 2011-08-19
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Daegu, KR

Download summary PDF View on FDA.gov ↗

Recent devices under product code EKX

K252223 — Alpha Endo Handpiece (Alpha Endo)2025-10-16
K251597 — InnerView System2025-09-18
K243692 — EnDrive (EnDriveUS)2025-08-22
K242514 — Endo Motor (E-LITE MAX, E-LITE PRO, E-LITE INO)2025-04-24
K241065 — ChecQ (AC100)2025-03-21

More clearances from Saeshin Precision Co., Ltd.

K251407 — Motor Handpiece and Control Unit (SDI10)2026-01-30
K233153 — Traus SSG10 Surgical System2024-09-20
K232938 — Traus SSG30 Surgical System2024-09-16
K221741 — TRAUS Air Dental Handpiece2023-02-22
K212043 — TRAUS ENDO2022-06-24

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