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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 a medical device manufactured by Saeshin Precision Co., Ltd.. It received FDA 510(k) clearance on 2026-01-30 under approval 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. It is manufactured by Saeshin Precision Co., Ltd.. The 510(k) number is K251407.

When was Motor Handpiece and Control Unit (SDI10) approved by the FDA?

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

What company makes Motor Handpiece and Control Unit (SDI10)?

Motor Handpiece and Control Unit (SDI10) is manufactured by Saeshin Precision Co., Ltd..

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.

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Related Devices (Code: EBW)

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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.

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