FDA 510(k)

치과 고속 터빈 핸드피스, 치과 저속 터빈 핸드피스

K-번호: K212910 · 2022-11-17

신청자Shenzhen Carejoy Technology Co., Ltd.

결정일2022-11-17

제품 코드EFB

자문 위원회의료 장비 규제 텍스트 번역 DE [회사명]의 [제품명]은 미국 식품의약국(FDA)에 등록된 의료 장비로, 510(k) 신청을 통해 승인을 받았습니다. 이 제품은 PMA(Premarket Approval)를 받지 않았으며, NCT(National Clinical Trial) 등록 번호는 [NCT 번호]입니다. PMID(Publication Medical Identifier)은 [PMID 번호]입니다. 더 자세한 정보는 다음 URL을 참조하세요: [URL]

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기기 요약

Dental High-speed Turbine Handpiece, Dental Low-speed Turbine Handpiece is the device name listed in this FDA 510(k) record. The listed applicant is Shenzhen Carejoy Technology Co., Ltd.. It received FDA 510(k) clearance on 2022-11-17 under 510(k) number K212910. The device is classified under product code EFB. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

자주 묻는 질문

What is the Dental High-speed Turbine Handpiece, Dental Low-speed Turbine Handpiece?

Dental High-speed Turbine Handpiece, Dental Low-speed Turbine Handpiece is a medical device that received FDA 510(k) clearance on 2022-11-17. The listed applicant is Shenzhen Carejoy Technology Co., Ltd.. The 510(k) number is K212910.

When did Dental High-speed Turbine Handpiece, Dental Low-speed Turbine Handpiece receive FDA 510(k) clearance?

Dental High-speed Turbine Handpiece, Dental Low-speed Turbine Handpiece received FDA 510(k) clearance on 2022-11-17, under 510(k) number K212910.

Who is the listed applicant for Dental High-speed Turbine Handpiece, Dental Low-speed Turbine Handpiece?

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

What is the FDA product code for Dental High-speed Turbine Handpiece, Dental Low-speed Turbine Handpiece?

The FDA product code for Dental High-speed Turbine Handpiece, Dental Low-speed Turbine Handpiece is EFB.

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FDA Open API에서 수집된 데이터입니다. 가장 정확하고 공인된 정보는 항상 공식 레코드를 참조하시기 바랍니다.

치과 고속 터빈 핸드피스, 치과 저속 터빈 핸드피스

기기 요약

자주 묻는 질문

관련 임상시험

관련 기기 (코드: EFB)

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