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pulpdent oil free surface preparation paste
Pulpdent
Summary: Pulpdent Oil Free Surface Preparation Paste is a dental device used for preparing tooth surfaces. It is primarily used by dental professionals during restorative procedures.
FDA Clearance Information
Pathway
510K
Number
K901052 ↗
Decision Date
April 16, 1990
Product Code
EJR
Device Class
Class 1
Evidence
0 studies
The device was cleared through the FDA 510(k) pathway on April 16, 1990. Manufactured by Pulpdent, it is classified as a Class 1 device under product code EJR.
What It Is
The Pulpdent Oil Free Surface Preparation Paste is a dental preparation product designed to clean and prepare tooth surfaces before restorative procedures. It helps in removing debris and contaminants, ensuring optimal adhesion of dental materials. The paste is oil-free, which is beneficial in maintaining a clean surface for bonding.
Clinical Applications
This device is commonly used in general dentistry and restorative dental practices. It is particularly useful in settings where tooth surface preparation is crucial, such as before applying sealants, bonding agents, or other restorative materials. Dental professionals use it to enhance the longevity and effectiveness of dental restorations.
Indications for Use
The device is indicated for use in preparing tooth surfaces prior to restorative procedures. It is suitable for patients requiring dental restorations, such as fillings or sealants, to ensure clean and effective bonding surfaces.
Practical Considerations
The paste is typically applied with a brush or applicator. It is compatible with most dental materials and does not require special storage conditions. Clinicians should ensure that the tooth surface is thoroughly cleaned and dried before application.
Frequently Asked Questions
What is Pulpdent Oil Free Surface Preparation Paste used for?
It is used to clean and prepare tooth surfaces before restorative dental procedures.
What specialties typically use this device?
General dentistry and restorative dental practices commonly use this device.
What are the FDA-cleared indications?
It is indicated for preparing tooth surfaces prior to restorative procedures to ensure effective bonding.
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.