FDA 510(k)

Portable Dental Unit (PC 2630, OMC 2375CV, MC 3600CV)

K-번호: K254009 · 2026-09-10

결정일2026-09-10

제품 코드SJH

자문 위원회DE

결정Substantially Equivalent

기기 요약

Portable Dental Unit (PC 2630, OMC 2375CV, MC 3600CV) is the device name listed in this FDA 510(k) record. The listed applicant is Lakong Medical Devices Co., Ltd.. It received FDA 510(k) clearance on 2026-09-10 under 510(k) number K254009. The device is classified under product code SJH. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

자주 묻는 질문

What is the Portable Dental Unit (PC 2630, OMC 2375CV, MC 3600CV)?

Portable Dental Unit (PC 2630, OMC 2375CV, MC 3600CV) is a medical device that received FDA 510(k) clearance on 2026-09-10. The listed applicant is Lakong Medical Devices Co., Ltd.. The 510(k) number is K254009.

When did Portable Dental Unit (PC 2630, OMC 2375CV, MC 3600CV) receive FDA 510(k) clearance?

Portable Dental Unit (PC 2630, OMC 2375CV, MC 3600CV) received FDA 510(k) clearance on 2026-09-10, under 510(k) number K254009.

Who is the listed applicant for Portable Dental Unit (PC 2630, OMC 2375CV, MC 3600CV)?

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

What is the FDA product code for Portable Dental Unit (PC 2630, OMC 2375CV, MC 3600CV)?

The FDA product code for Portable Dental Unit (PC 2630, OMC 2375CV, MC 3600CV) is SJH.

Lakong Medical Devices Co., Ltd.를 신청인으로 등재한 기타 기록

K251544Dental Unit (MP2000-550LED-2.0, LP2100-550LED-2.0)

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기기 요약

자주 묻는 질문

관련 임상시험

Lakong Medical Devices Co., Ltd.를 신청인으로 등재한 기타 기록

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