FDA 510(k)

ArgenZ Liquid Shade, ArgenZ Incisal Effect, ArgenZ Color Modifier, ArgenZ Pontic Reducer

K-번호: K182833 · 2019-02-08

결정일2019-02-08

제품 코드EIH

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]

결정Substantially Equivalent

기기 요약

ArgenZ Liquid Shade, ArgenZ Incisal Effect, ArgenZ Color Modifier, ArgenZ Pontic Reducer is the device name listed in this FDA 510(k) record. The listed applicant is The Argen Corporation. It received FDA 510(k) clearance on 2019-02-08 under 510(k) number K182833. The device is classified under product code EIH. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

자주 묻는 질문

What is the ArgenZ Liquid Shade, ArgenZ Incisal Effect, ArgenZ Color Modifier, ArgenZ Pontic Reducer?

ArgenZ Liquid Shade, ArgenZ Incisal Effect, ArgenZ Color Modifier, ArgenZ Pontic Reducer is a medical device that received FDA 510(k) clearance on 2019-02-08. The listed applicant is The Argen Corporation. The 510(k) number is K182833.

When did ArgenZ Liquid Shade, ArgenZ Incisal Effect, ArgenZ Color Modifier, ArgenZ Pontic Reducer receive FDA 510(k) clearance?

ArgenZ Liquid Shade, ArgenZ Incisal Effect, ArgenZ Color Modifier, ArgenZ Pontic Reducer received FDA 510(k) clearance on 2019-02-08, under 510(k) number K182833.

Who is the listed applicant for ArgenZ Liquid Shade, ArgenZ Incisal Effect, ArgenZ Color Modifier, ArgenZ Pontic Reducer?

The FDA 510(k) record lists The Argen Corporation as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for ArgenZ Liquid Shade, ArgenZ Incisal Effect, ArgenZ Color Modifier, ArgenZ Pontic Reducer?

The FDA product code for ArgenZ Liquid Shade, ArgenZ Incisal Effect, ArgenZ Color Modifier, ArgenZ Pontic Reducer is EIH.

The Argen Corporation를 신청인으로 등재한 기타 기록

K190079ArgenZ HT+

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