X-CUBE— 510(k) K092758

Substantially Equivalent

Saeshin Precision Co., Ltd.

FDA 510(k) clearance K092758 for X-CUBE, Substantially Equivalent on 2009-09-21. Applicant: Saeshin Precision Co., Ltd.. Device class: 1.

Clearance details

Applicant: Saeshin Precision Co., Ltd.
Product code: Product code EBW
Device class: Class 1
Regulation: 21 CFR 872.4200
Advisory panel: Dental
Date received: 2009-09-09
Decision date: 2009-09-21
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Daegu, KR

Download summary PDF View on FDA.gov ↗

Recent devices under product code EBW

K260027 — Firstar Dental Electric Motor2026-10-01
K251407 — Motor Handpiece and Control Unit (SDI10)2026-01-30
K251701 — Star E900 Electric System2026-01-12
K251811 — Motor and Apex Module (MaAM)2025-08-25
K231562 — ELEC ENGINE (Model: ISE-170L)2025-07-18

More clearances from Saeshin Precision Co., Ltd.

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
K201292 — TRAUS SIP202021-02-11

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