đź“‹ FDA Reference
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 ?
510(k)
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.
FDA-Cleared Indications
- Reconstruction of damaged or missing tooth structure during dental restorative treatment.
- Core build-up of a tooth to provide support for a subsequent restoration, such as a crown.
Clinical Applications
- Building up the coronal portion of a tooth after substantial loss of tooth structure.
- Reconstructing tooth structure affected by dental decay.
- Rebuilding tooth structure damaged by trauma.
- Creating a foundation for placement of a dental crown.
Practical Considerations
- The material is delivered through an automix system for proportioned mixing and direct application.
- Proper tooth isolation and standard dental bonding techniques are important for adhesion and handling.
- Clinicians should confirm compatibility with the intended bonding or adhesive system and follow the product labeling for preparation, curing, and finishing.
- The material is used in the oral cavity and is not an implantable vascular or other MRI-relevant device; MRI safety labeling is generally not applicable to the cured dental material.
- Contraindications, preparation requirements, setting time, storage conditions, and available shades should be confirmed in the current manufacturer instructions.
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.