FDA 510(k)

DENU Light Body(Regular, Fast), DENU Heavy Body(Regular, Fast), DENU Putty Set(Regular, Fast)

K-번호: K222741 · 2022-11-07

결정일2022-11-07

제품 코드ELW

자문 위원회DE

결정Substantially Equivalent

기기 요약

DENU Light Body(Regular, Fast), DENU Heavy Body(Regular, Fast), DENU Putty Set(Regular, Fast) is the device name listed in this FDA 510(k) record. The listed applicant is Hdi, Inc.. It received FDA 510(k) clearance on 2022-11-07 under 510(k) number K222741. The device is classified under product code ELW. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

자주 묻는 질문

What is the DENU Light Body(Regular, Fast), DENU Heavy Body(Regular, Fast), DENU Putty Set(Regular, Fast)?

DENU Light Body(Regular, Fast), DENU Heavy Body(Regular, Fast), DENU Putty Set(Regular, Fast) is a medical device that received FDA 510(k) clearance on 2022-11-07. The listed applicant is Hdi, Inc.. The 510(k) number is K222741.

When did DENU Light Body(Regular, Fast), DENU Heavy Body(Regular, Fast), DENU Putty Set(Regular, Fast) receive FDA 510(k) clearance?

DENU Light Body(Regular, Fast), DENU Heavy Body(Regular, Fast), DENU Putty Set(Regular, Fast) received FDA 510(k) clearance on 2022-11-07, under 510(k) number K222741.

Who is the listed applicant for DENU Light Body(Regular, Fast), DENU Heavy Body(Regular, Fast), DENU Putty Set(Regular, Fast)?

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

What is the FDA product code for DENU Light Body(Regular, Fast), DENU Heavy Body(Regular, Fast), DENU Putty Set(Regular, Fast)?

The FDA product code for DENU Light Body(Regular, Fast), DENU Heavy Body(Regular, Fast), DENU Putty Set(Regular, Fast) is ELW.

Hdi, Inc.를 신청인으로 등재한 기타 기록

K213339DENU Composite Resin, DENU Flow Resin

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