FDA 510(k)

IPS CaseDesigner

K号: K161634 · 2016-11-10

决定日期2016-11-10

产品代码LLZ

咨询委员会RA

决定Substantially Equivalent

器械摘要

IPS CaseDesigner is the device name listed in this FDA 510(k) record. The listed applicant is Nobel Biocare AB. It received FDA 510(k) clearance on 2016-11-10 under 510(k) number K161634. The device is classified under product code LLZ. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the IPS CaseDesigner?

IPS CaseDesigner is a medical device that received FDA 510(k) clearance on 2016-11-10. The listed applicant is Nobel Biocare AB. The 510(k) number is K161634.

When did IPS CaseDesigner receive FDA 510(k) clearance?

IPS CaseDesigner received FDA 510(k) clearance on 2016-11-10, under 510(k) number K161634.

Who is the listed applicant for IPS CaseDesigner?

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

What is the FDA product code for IPS CaseDesigner?

The FDA product code for IPS CaseDesigner is LLZ.

列明Nobel Biocare AB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。

K253988LiteSet Trays K253999Universal Base ASC Engaging; Universal Base ASC Non-Engaging; Universal Base MUA ASC; Temporary Abutment Engaging and Non-Engaging; Healing Abutment Conical Connection; Omnigrip Clinical Screw Titanium; Omnigrip Prosthetic Screw K252197Nobel Biocare S Series Implants K243834NobelZygoma TiUltra Implant system K240346NobelProcera Zirconia Implant Bridge K233208NobelProcera Titanium ASC Abutment, Omnigrip Clinical Screw Titanium

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官方来源

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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。