Motor Handpiece and Control Unit (SDI10)— 510(k) K251407

Name: FDA 510(k) clearance K251407
Creator: U.S. Food and Drug Administration
Published: 2026-01-30

Substantially Equivalent

Saeshin Precision Co., Ltd.

FDA 510(k) clearance K251407 for Motor Handpiece and Control Unit (SDI10), Substantially Equivalent on 2026-01-30. Applicant: Saeshin Precision Co., Ltd.. Device class: 1.

Clearance details

Applicant: Saeshin Precision Co., Ltd.
Product code: Code EBW
Device class: Class 1
Regulation: 21 CFR 872.4200
Advisory panel: Dental
Date received: 2025-05-06
Decision date: 2026-01-30
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Deagu, KR

Download summary PDF View on FDA.gov ↗

Recent devices under product code EBW

view all

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
K242646 — Dental Implant Unit2025-04-11
K233288 — NLZ Built-In Motor System2024-06-24

More clearances from Saeshin Precision Co., Ltd.

view all

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.