Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

LEGACY3 6MM LENGTH IMPLANTS

K-Number: K131097 · 2013-08-22

ApplicantImplant Direct Sybron Manufacturing, LLC
Decision Date2013-08-22
Product CodeDZE
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

LEGACY3 6MM LENGTH IMPLANTS is the device name listed in this FDA 510(k) record. The listed applicant is Implant Direct Sybron Manufacturing, LLC. It received FDA 510(k) clearance on 2013-08-22 under 510(k) number K131097. 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 LEGACY3 6MM LENGTH IMPLANTS?

LEGACY3 6MM LENGTH IMPLANTS is a medical device that received FDA 510(k) clearance on 2013-08-22. The listed applicant is Implant Direct Sybron Manufacturing, LLC. The 510(k) number is K131097.

When did LEGACY3 6MM LENGTH IMPLANTS receive FDA 510(k) clearance?

LEGACY3 6MM LENGTH IMPLANTS received FDA 510(k) clearance on 2013-08-22, under 510(k) number K131097.

Who is the listed applicant for LEGACY3 6MM LENGTH IMPLANTS?

The FDA 510(k) record lists Implant Direct Sybron Manufacturing, LLC as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for LEGACY3 6MM LENGTH IMPLANTS?

The FDA product code for LEGACY3 6MM LENGTH IMPLANTS is DZE.

Related Clinical Trials

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.

NCT07608549FLASH Pilot Phase 1 Safety StudyNOT_YET_RECRUITINGNCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITINGNCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDEDNCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

Other records listing Implant Direct Sybron Manufacturing, LLC 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.

K231087Guided Surgery KitK223535SMARTbase Abutment SystemK222211Implant Direct Dental Implant Systems Portfolio - MR ConditionalK202524Standard Sterilizable TrayK201553Simply Iconic ImplantsK200858Mini Sterilizable Tray

View all 15 devices →

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.

↑