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zenith luxacore automix core material multiple
Foremost Dental Mfg.
Summary: The Zenith Luxacore Automix Core Material is a dental core build-up material used by dentists for reconstructing tooth structure. It is primarily used in restorative dentistry to provide a strong foundation for crowns.
FDA Clearance Information
Pathway
510K
Number
K982201 ↗
Decision Date
August 10, 1998
Product Code
EBF
Device Class
Class 2
Evidence
35 studies
The Zenith Luxacore Automix Core Material was cleared through the FDA 510(k) pathway on August 10, 1998. Manufactured by Foremost Dental Mfg., it is classified as a Class 2 device under product code EBF.
What It Is
The Zenith Luxacore Automix Core Material is a dental material designed for core build-up procedures. It is an automix system, allowing for easy and precise application directly onto the tooth structure. This material is used to rebuild the coronal portion of a tooth that has been damaged or decayed, providing a stable base for subsequent crown placement.
Clinical Applications
This device is commonly used in restorative dental procedures, particularly in cases where significant tooth structure has been lost due to decay or trauma. Dentists in general practice and specialists in prosthodontics frequently use this material in both private practice and hospital settings. It is suitable for adult patients requiring tooth restoration prior to crown placement.
Indications for Use
The FDA indications for this device include its use in dental procedures to reconstruct tooth structure. It is intended for patients who need a core build-up to support a dental crown, often following root canal treatment or extensive decay.
Practical Considerations
The Zenith Luxacore Automix Core Material is typically available in various shades to match natural tooth color. It is compatible with most dental bonding systems and requires standard dental techniques for application. Clinicians should ensure proper isolation of the tooth during the procedure to achieve optimal results.
Linked Studies (20)
PubMed • 2025
Outcomes of patients with acute complicated type B aortic dissections repaired with the Zenith dissection endovascular system compared to aortic stent graft.
Vascular
RCT|prospective|retrospective|case Series|other View Source →
PubMed • 2025
Gingival zenith level, position, and symmetry: A systematic review and meta-analysis.
The Journal of prosthetic dentistry
RCT|prospective|retrospective|case Series|other View Source →
PubMed • 2024
Expert-Based Narrative Review on Contemporary Use of an Off-The-Shelf Multibranched Endograft for Endovascular Treatment of Thoracoabdominal Aortic Aneurysms: Device Design, Anatomical Suitability, Technical Tips, Perioperative Care, Clinical Applications, and Real-World Experience.
Annals of vascular surgery
View Source →
PubMed • 2024
Exploring atmospheric optical turbulence: observations across zenith angles.
Applied optics
RCT|prospective|retrospective|case Series|other View Source →
PubMed • 2024
Cook Zenith Alpha Endograft: A Protocol to Minimise Limb Graft Occlusion.
European journal of vascular and endovascular surgery : the official journal of the European Society for Vascular Surgery
RCT|prospective|retrospective|case Series|other View Source →
PubMed • 2024
Gingival Zenith Correction by Laser Gingivectomy.
Cureus
RCT|prospective|retrospective|case Series|other View Source →
PubMed • 2023
A Retrospective Evaluation of Intra-Prosthetic Thrombus Formation After Endovascular Aortic Repair in Cook Zenith Alpha and Medtronic Endurant II Patients.
European journal of vascular and endovascular surgery : the official journal of the European Society for Vascular Surgery
Retrospective View Source →
PubMed • 2023
Emergent endovascular treatment options for thoracoabdominal aortic aneurysm.
Seminars in vascular surgery
View Source →
PubMed • 2023
Commentary: Data zenith.
The Journal of thoracic and cardiovascular surgery
View Source →
PubMed • 2022
Placement of a Zenith® Dissection Endovascular System in the Descending Thoracic Aorta Can Hamper Further Surgical Aortic Operations.
EJVES vascular forum
RCT|prospective|retrospective|case Series|other View Source →
PubMed • 2022
Midterm outcomes of aneurysm repair with the Cook Zenith Alpha abdominal endovascular graft.
Journal of vascular surgery
RCT|prospective|retrospective|case Series|other View Source →
PubMed • 2021
Comparison of anatomic feasibility of three different multibranched off-the-shelf stent-grafts designed for thoracoabdominal aortic aneurysms.
Journal of vascular surgery
RCT|prospective|retrospective|case Series|other View Source →
PubMed • 2021
New Technical Approach to Overcome Anatomical Challenges During Branched Endovascular Aortic Repair with off-the-Shelf Multibranched Stent-Grafts: Are We Sequentially and Progressively Scraping the Sky? : Commentary on "Sequential catheterization and progressive deployment of the Zenith tBranchTM device for branched endovascular aortic aneurysm repair".
Cardiovascular and interventional radiology
View Source →
PubMed • 2021
Kinematic Zenith Tropospheric Delay Estimation with GNSS PPP in Mountainous Areas.
Sensors (Basel, Switzerland)
View Source →
PubMed • 2020
Five-year results from the Study of Thoracic Aortic Type B Dissection Using Endoluminal Repair (STABLE I) study of endovascular treatment of complicated type B aortic dissection using a composite device design.
Journal of vascular surgery
RCT|prospective|retrospective|case Series|other View Source →
PubMed • 2020
Physician-Modified Endograft With Double Inner Branches for Urgent Repair of Supraceliac Para-Anastomotic Pseudoaneurysm.
Journal of endovascular therapy : an official journal of the International Society of Endovascular Specialists
RCT|prospective|retrospective|case Series|other View Source →
PubMed • 2019
Device profile of the Zenith Dissection Endovascular System for aortic dissection.
Expert review of medical devices
RCT|prospective|retrospective|case Series|other View Source →
PubMed • 2016
Thoracic endovascular aortic repair for complicated chronic type B aortic dissection in a patient on hemodialysis with recurrent ischemic colitis.
Surgical case reports
Case Series View Source →
PubMed • 2015
Surgeon custom-made iliac branch device to salvage hypogastric artery during endovascular aneurysm repair.
Journal of Korean medical science
RCT|prospective|retrospective|case Series|other View Source →
PubMed • 2014
Experience of the Zenith Dissection Endovascular System in the emergency setting of malperfusion in acute type B dissections.
Journal of vascular surgery
RCT|prospective|retrospective|case Series|other View Source →Frequently Asked Questions
What is Zenith Luxacore Automix Core Material used for?
It is used for core build-up in dental restorative procedures to provide a foundation for crowns.
What specialties typically use this device?
General dentists and prosthodontists commonly use this device in restorative dentistry.
What are the FDA-cleared indications?
It is indicated for reconstructing tooth structure to support a crown, especially after decay or root canal treatment.
Disclaimer: This page compiles publicly available regulatory and published clinical evidence for educational reference.
It does not constitute medical advice, product endorsement, or a recommendation for clinical use.
Always consult manufacturer documentation and clinical judgment for patient care decisions.