FDA 510(k)

JET SET 4 DENTURE REPAIR RESIN

K号: K152981 · 2016-09-02

申请人Lang Dental Manufacturing Company, Inc.

决定日期2016-09-02

产品代码EBI

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决定实质等同

器械摘要

JET SET 4 DENTURE REPAIR RESIN is the device name listed in this FDA 510(k) record. The listed applicant is Lang Dental Manufacturing Company, Inc.. It received FDA 510(k) clearance on 2016-09-02 under 510(k) number K152981. The device is classified under product code EBI. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the JET SET 4 DENTURE REPAIR RESIN?

JET SET 4 DENTURE REPAIR RESIN is a medical device that received FDA 510(k) clearance on 2016-09-02. The listed applicant is Lang Dental Manufacturing Company, Inc.. The 510(k) number is K152981.

When did JET SET 4 DENTURE REPAIR RESIN receive FDA 510(k) clearance?

JET SET 4 DENTURE REPAIR RESIN received FDA 510(k) clearance on 2016-09-02, under 510(k) number K152981.

Who is the listed applicant for JET SET 4 DENTURE REPAIR RESIN?

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

What is the FDA product code for JET SET 4 DENTURE REPAIR RESIN?

The FDA product code for JET SET 4 DENTURE REPAIR RESIN is EBI.

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JET SET 4 DENTURE REPAIR RESIN

器械摘要

常见问题

相关临床试验

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官方来源