Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

Motor Handpiece and Control Unit (SDI10)

K-Number: K251407 · 2026-01-30

ApplicantSaeshin Precision Co., Ltd.
Decision Date2026-01-30
Product CodeEBW
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

Motor Handpiece and Control Unit (SDI10) is the device name listed in this FDA 510(k) record. The listed applicant is Saeshin Precision Co., Ltd.. It received FDA 510(k) clearance on 2026-01-30 under 510(k) number K251407. The device is classified under product code EBW. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Motor Handpiece and Control Unit (SDI10)?

Motor Handpiece and Control Unit (SDI10) is a medical device that received FDA 510(k) clearance on 2026-01-30. The listed applicant is Saeshin Precision Co., Ltd.. The 510(k) number is K251407.

When did Motor Handpiece and Control Unit (SDI10) receive FDA 510(k) clearance?

Motor Handpiece and Control Unit (SDI10) received FDA 510(k) clearance on 2026-01-30, under 510(k) number K251407.

Who is the listed applicant for Motor Handpiece and Control Unit (SDI10)?

The FDA 510(k) record lists Saeshin Precision Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Motor Handpiece and Control Unit (SDI10)?

The FDA product code for Motor Handpiece and Control Unit (SDI10) is EBW.

Other records listing Saeshin Precision Co., Ltd. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K233153Traus SSG10 Surgical SystemK232938Traus SSG30 Surgical SystemK221741TRAUS Air Dental HandpieceK212043TRAUS ENDOK201292TRAUS SIP20K192561TRAUS SUS20

View all 10 devices →

Related Devices (Code: EBW)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K251701Star E900 Electric SystemDentalez, Inc., Stardental DivisionK251811Motor and Apex Module (MaAM)Dentsply Sirona, Inc.K231562ELEC ENGINE (Model: ISE-170L)Micro-Nx Co., Ltd.K242646Dental Implant UnitGuilin Aesthedent Medical Instruments Co., Ltd.K233288NLZ Built-In Motor SystemNakanishi, Inc.K233117Surgic Pro2 (Surgic Pro2 OPT), Surgic Pro2 (Surgic Pro2 NON-OPT)Nakanishi, Inc.

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

↑