FDA 510(k)

Simply Iconic Implants

K号: K201553 · 2021-01-22

申请人Implant Direct Sybron Manufacturing, LLC

决定日期2021-01-22

产品代码DZE

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决定实质等同

器械摘要

Simply Iconic Implants is the device name listed in this FDA 510(k) record. The listed applicant is Implant Direct Sybron Manufacturing, LLC. It received FDA 510(k) clearance on 2021-01-22 under 510(k) number K201553. The device is classified under product code DZE. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the Simply Iconic Implants?

Simply Iconic Implants is a medical device that received FDA 510(k) clearance on 2021-01-22. The listed applicant is Implant Direct Sybron Manufacturing, LLC. The 510(k) number is K201553.

When did Simply Iconic Implants receive FDA 510(k) clearance?

Simply Iconic Implants received FDA 510(k) clearance on 2021-01-22, under 510(k) number K201553.

Who is the listed applicant for Simply Iconic Implants?

The FDA 510(k) record lists Implant Direct Sybron Manufacturing, LLC as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Simply Iconic Implants?

The FDA product code for Simply Iconic Implants is DZE.

列明Implant Direct Sybron Manufacturing, LLC为申报人的其他记录

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