đź“‹ FDA Reference
super-dent etching gel super-dent micro-etch gel and super-dent etching gel syringe tips
S.S. White Mfg.
Summary: The Super-Dent Etching Gel is a dental device used primarily for etching enamel and dentin in preparation for bonding procedures. It is typically used by dental professionals in clinical settings.
FDA Clearance Information
Pathway
510K
Number
K964179 ↗
Decision Date
January 9, 1997
Product Code
EBF
Device Class
Class 2
Evidence
0 studies
The Super-Dent Etching Gel, manufactured by S.S. White Mfg., was cleared through the FDA 510(k) pathway on January 9, 1997. It is classified as a Class 2 device under product code EBF.
What It Is
The Super-Dent Etching Gel is a dental etching product designed to prepare tooth surfaces for bonding by creating a roughened surface, which enhances adhesion. It is typically applied to enamel and dentin surfaces before the placement of restorative materials such as composite resins. The gel is available in a syringe form, allowing precise application.
Clinical Applications
This etching gel is commonly used in restorative dental procedures, such as filling cavities, placing veneers, and bonding orthodontic brackets. It is utilized by general dentists, orthodontists, and other dental specialists in both private practices and institutional settings. The gel is suitable for use in patients requiring dental restorations or orthodontic treatments.
Indications for Use
The FDA indications suggest that this device is used for etching enamel and dentin to prepare teeth for bonding procedures. It is suitable for patients undergoing restorative or orthodontic treatments requiring enhanced adhesion of dental materials.
Practical Considerations
The gel is typically available in syringes with tips for easy application. It is important to follow the manufacturer's instructions for application time and technique to ensure optimal results. Compatibility with various bonding agents should be considered.
Related Literature
The linked study investigated the recovery and identification of mature enamel proteins from ancient teeth using a micro-etch technique. The study successfully extracted enamel protein samples from both recent and ancient molars, analyzed using mass spectrometry. While the study highlights the potential of micro-etch techniques in protein recovery, it is limited by the small sample size and specific focus on ancient teeth.
Frequently Asked Questions
What is Super-Dent Etching Gel used for?
It is used for etching enamel and dentin to prepare tooth surfaces for bonding in dental procedures.
What specialties typically use this device?
General dentists, orthodontists, and other dental specialists use this device in restorative and orthodontic procedures.
What are the FDA-cleared indications?
The gel is indicated for etching enamel and dentin to enhance adhesion during bonding procedures in dental treatments.
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.