FDA 510(k)

Z5MLB, Z5MLC

K-Number: K131701 · 2013-09-05

Decision Date2013-09-05

Product CodeDZE

Advisory CommitteeDE

DecisionSubstantially Equivalent

Device Summary

Z5MLB, Z5MLC is the device name listed in this FDA 510(k) record. The listed applicant is Z-Systems AG. It received FDA 510(k) clearance on 2013-09-05 under 510(k) number K131701. The device is classified under product code DZE. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Z5MLB, Z5MLC?

Z5MLB, Z5MLC is a medical device that received FDA 510(k) clearance on 2013-09-05. The listed applicant is Z-Systems AG. The 510(k) number is K131701.

When did Z5MLB, Z5MLC receive FDA 510(k) clearance?

Z5MLB, Z5MLC received FDA 510(k) clearance on 2013-09-05, under 510(k) number K131701.

Who is the listed applicant for Z5MLB, Z5MLC?

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

What is the FDA product code for Z5MLB, Z5MLC?

The FDA product code for Z5MLB, Z5MLC is DZE.

Other records listing Z-Systems AG as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K201878ST-Z5 K201712Z5-TL K200386Z5-BL K190243Z5-BL K120793Z-LOOK3 EVO SLM K062542Z-LOOK3 DENTAL IMPLANT SYSTEM, MODEL Z3-XXX

View all 7 devices →

Related Devices (Code: DZE)

K261392TriActive Dental Implant SystemParagon Implant Mfg., LLC K260463ZEROS Dental Implant SystemZeros Co., Ltd.K251188UNIQA® Dental Implants SystemUniqa Dental, Ltd.K251232MegaGen Zygoma Dental Implant SystemMegagen Implant Co., Ltd.K250806Dental Implant SystemA.B. Dental Devices , Ltd.K260006INOSS SystemInosys, Inc.

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.