đź“‹ FDA Reference
Zenith Total Etch 10 Phosphoric Acid
Foremost Dental Mfg.
Summary: The Zenith Total Etch 10 is a phosphoric acid etchant used in dental procedures to prepare tooth surfaces for bonding. It is primarily used by dentists and dental specialists.
FDA Clearance Information
Pathway ?
510(k)
Number ?
K935032 ↗
Decision Date ?
January 18, 1994
Product Code ?
EBF
Device Class ?
Class 2
Evidence ?
35 studies
The Zenith Total Etch 10 Phosphoric Acid was cleared through the FDA 510(k) pathway on January 18, 1994. It is manufactured by Foremost Dental Mfg. and classified as a Class 2 device under product code EBF.
What It Is
The Zenith Total Etch 10 is a dental etchant containing 10% phosphoric acid, designed to prepare enamel and dentin surfaces for bonding procedures. By removing the smear layer and creating micro-porosities, it enhances the adhesion of dental materials. This etchant is typically used in restorative dentistry to ensure strong bonding of composite resins and other restorative materials.
FDA-Cleared Indications
- Preparation of tooth surfaces before bonding dental materials.
- Etching enamel and dentin to improve adhesion of restorative materials.
Clinical Applications
- Preparing tooth surfaces before placement of bonded composite restorations.
- Preparing enamel and dentin for adhesive restorative procedures.
- Preparing tooth surfaces before bonding veneers or other dental restorations.
- Preparing enamel surfaces before bonding orthodontic brackets when included in the applicable dental bonding procedure.
Practical Considerations
- The product contains 10% phosphoric acid and should be used according to its current labeling and the clinician's bonding system instructions.
- Application time depends on the tooth surface and the associated adhesive system; clinicians should follow the product instructions rather than relying on a standard time.
- Use proper isolation to limit contact with gingiva, oral mucosa and other soft tissues.
- The etchant must be compatible with the selected bonding agent and restorative material.
- This is a topical dental chemical, not an implantable device; MRI precautions and device-sizing considerations do not apply.
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 Total Etch 10 used for?
It is used to prepare tooth surfaces for bonding in dental procedures, enhancing the adhesion of restorative materials.
What specialties typically use this device?
This device is primarily used by general dentists and dental specialists in restorative dentistry.
What are the FDA-cleared indications?
It is indicated for preparing tooth surfaces for bonding, suitable for dental restorations like fillings and veneers.
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.