📋 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 ?
510(k)
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.
FDA-Cleared Indications
- Etching enamel surfaces before bonding procedures.
- Etching dentin surfaces before bonding procedures.
Clinical Applications
- Preparing enamel for bonding restorative dental materials.
- Preparing dentin for bonding restorative dental materials.
- Preparing tooth surfaces before placement of bonded dental restorations.
- Preparing tooth surfaces before orthodontic bonding procedures.
Practical Considerations
- Use only according to the manufacturer's instructions, including the labeled application technique and etching time.
- The gel is supplied in syringe form with syringe tips intended to support controlled placement on tooth surfaces.
- Compatibility with the selected dental bonding agent and restorative material should be confirmed before use.
- Avoid unintended contact with soft tissues, eyes, and other non-target surfaces; dental professionals should use appropriate isolation and protective measures.
- This is a dental chemical etchant and is not an implant, catheter, or imaging device; MRI safety labeling is not generally applicable.
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.