FDA 510(k)

Air-Powered Handpieces and Handpiece Attachments

K-번호: K162926 · 2017-02-23

결정일2017-02-23

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

Air-Powered Handpieces and Handpiece Attachments is the device name listed in this FDA 510(k) record. The listed applicant is W&H Dentalwerk Burmoos GmbH. It received FDA 510(k) clearance on 2017-02-23 under 510(k) number K162926. 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 Air-Powered Handpieces and Handpiece Attachments?

Air-Powered Handpieces and Handpiece Attachments is a medical device that received FDA 510(k) clearance on 2017-02-23. The listed applicant is W&H Dentalwerk Burmoos GmbH. The 510(k) number is K162926.

When did Air-Powered Handpieces and Handpiece Attachments receive FDA 510(k) clearance?

Air-Powered Handpieces and Handpiece Attachments received FDA 510(k) clearance on 2017-02-23, under 510(k) number K162926.

Who is the listed applicant for Air-Powered Handpieces and Handpiece Attachments?

The FDA 510(k) record lists W&H Dentalwerk Burmoos GmbH as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Air-Powered Handpieces and Handpiece Attachments?

The FDA product code for Air-Powered Handpieces and Handpiece Attachments is EFB.

W&H Dentalwerk Burmoos GmbH를 신청인으로 등재한 기타 기록

K161957W&H 임플란트메드 SI-1015 포함 부속품

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