FDA 510(k)

n!ce LT Glass Ceramic Blocks, n!ce HT Glass Ceramic Blocks,

K号: K160262 · 2016-09-16

决定日期2016-09-16

产品代码EIH

咨询委员会DE

决定Substantially Equivalent

器械摘要

n!ce LT Glass Ceramic Blocks, n!ce HT Glass Ceramic Blocks, is the device name listed in this FDA 510(k) record. The listed applicant is Institut Straumann AG. It received FDA 510(k) clearance on 2016-09-16 under 510(k) number K160262. The device is classified under product code EIH. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the n!ce LT Glass Ceramic Blocks, n!ce HT Glass Ceramic Blocks,?

n!ce LT Glass Ceramic Blocks, n!ce HT Glass Ceramic Blocks, is a medical device that received FDA 510(k) clearance on 2016-09-16. The listed applicant is Institut Straumann AG. The 510(k) number is K160262.

When did n!ce LT Glass Ceramic Blocks, n!ce HT Glass Ceramic Blocks, receive FDA 510(k) clearance?

n!ce LT Glass Ceramic Blocks, n!ce HT Glass Ceramic Blocks, received FDA 510(k) clearance on 2016-09-16, under 510(k) number K160262.

Who is the listed applicant for n!ce LT Glass Ceramic Blocks, n!ce HT Glass Ceramic Blocks,?

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

What is the FDA product code for n!ce LT Glass Ceramic Blocks, n!ce HT Glass Ceramic Blocks,?

The FDA product code for n!ce LT Glass Ceramic Blocks, n!ce HT Glass Ceramic Blocks, is EIH.

列明Institut Straumann AG为申报人的其他记录

关联记录通过名称、产品代码或其他元数据自动匹配。匹配不意味着已验证临床、科学、企业或监管关系；请查阅链接的官方来源。

K260726Straumann® ProClean™ Cassette (041.800 ; 041.801)K260460Neodent Gold Hue Custom Abutments, Medentika Custom Abutments Gold Hue K252168Straumann® BLC Implants - Indication Widening K253315Straumann Variobase Abutments XC for Bridge/Bar K250294Straumann® RidgeFit Implants K243278Custom Abutments

查看所有 57 个设备 →

官方来源

在 FDA 数据库中查看 →

数据来源于FDA开放API。如需最新且权威的信息，请务必参考官方记录。