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FDA 510(k)

Z-LOOK3 DENTAL IMPLANT SYSTEM, MODEL Z3-XXX

K-Number: K062542 · 2007-10-29

ApplicantZ-Systems AG
Decision Date2007-10-29
Product CodeDZE
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

Z-LOOK3 DENTAL IMPLANT SYSTEM, MODEL Z3-XXX 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 2007-10-29 under 510(k) number K062542. 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 Z-LOOK3 DENTAL IMPLANT SYSTEM, MODEL Z3-XXX?

Z-LOOK3 DENTAL IMPLANT SYSTEM, MODEL Z3-XXX is a medical device that received FDA 510(k) clearance on 2007-10-29. The listed applicant is Z-Systems AG. The 510(k) number is K062542.

When did Z-LOOK3 DENTAL IMPLANT SYSTEM, MODEL Z3-XXX receive FDA 510(k) clearance?

Z-LOOK3 DENTAL IMPLANT SYSTEM, MODEL Z3-XXX received FDA 510(k) clearance on 2007-10-29, under 510(k) number K062542.

Who is the listed applicant for Z-LOOK3 DENTAL IMPLANT SYSTEM, MODEL Z3-XXX?

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 Z-LOOK3 DENTAL IMPLANT SYSTEM, MODEL Z3-XXX?

The FDA product code for Z-LOOK3 DENTAL IMPLANT SYSTEM, MODEL Z3-XXX is DZE.

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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-Z5K201712Z5-TLK200386Z5-BLK190243Z5-BLK131701Z5MLB, Z5MLCK120793Z-LOOK3 EVO SLM

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Related Devices (Code: DZE)

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.

K261392TriActive Dental Implant SystemParagon Implant Mfg., LLCK260463ZEROS 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.

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