FDA 510(k)

Straumann BLX 金色基台

K号: K200597 · 2020-08-19

申请人Straumann USA, LLC (On Behalf of Institut Straumann Ag)

决定日期2020-08-19

产品代码NHA

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决定实质等同

器械摘要

Straumann BLX Gold Abutments is the device name listed in this FDA 510(k) record. The listed applicant is Straumann USA, LLC (On Behalf of Institut Straumann Ag). It received FDA 510(k) clearance on 2020-08-19 under 510(k) number K200597. The device is classified under product code NHA. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the Straumann BLX Gold Abutments?

Straumann BLX Gold Abutments is a medical device that received FDA 510(k) clearance on 2020-08-19. The listed applicant is Straumann USA, LLC (On Behalf of Institut Straumann Ag). The 510(k) number is K200597.

When did Straumann BLX Gold Abutments receive FDA 510(k) clearance?

Straumann BLX Gold Abutments received FDA 510(k) clearance on 2020-08-19, under 510(k) number K200597.

Who is the listed applicant for Straumann BLX Gold Abutments?

The FDA 510(k) record lists Straumann USA, LLC (On Behalf of Institut Straumann Ag) as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Straumann BLX Gold Abutments?

The FDA product code for Straumann BLX Gold Abutments is NHA.

列明Straumann USA, LLC (On Behalf of Institut Straumann Ag)为申报人的其他记录

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相关器械（代码：NHA）

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