TEMPFIL F

K963786 · Sybron Dental Specialties, Inc. · EBG · Nov 19, 1996 · Dental

Device Facts

• Record ID: K963786
• Device Name: TEMPFIL F
• Applicant: Sybron Dental Specialties, Inc.
• Product Code: EBG · Dental
• Decision Date: Nov 19, 1996
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.3770
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

Provisional or temporary restorative materials are used in dentistry for treatment procedures not intended to be permanent or final. The purpose of the temporary material is to protect a prepared tooth surface during the interim period until the permanent restoration is available. An example of this interim period is the time that passes while porcelain or metal prosthetic devices are being fabricated in a dental laboratory. Another purpose of a temporary restoration is to provide an esthetically pleasing appearance for the patient during this interim period.

Device Story

TempFil F is a visible light-activated, no-mix temporary restorative material supplied in two formulations: Inlay (lower viscosity) and Onlay (higher filler loading, additional crosslinking monomer for hardness). Used by dentists in clinical settings to protect prepared teeth during prosthetic fabrication. Material provides fluoride release and maintains elasticity for easy removal without damaging margins. Kit includes 'Relief' water-soluble gel to prevent adhesion to underlying liners. Device replaces traditional chemically cured systems, offering improved convenience and placement ease.

Clinical Evidence

Bench testing only. Biocompatibility testing conducted per ISO 10993, including Ames Mutagenicity Assay, Cytotoxicity Study (Agarose Overlay), and Kligman Maximization Study (Tissue Sensitization). Performance compared to predicate devices (Fermit, E-Z Temp, Clip) via in-house side-by-side testing.

Technological Characteristics

Visible light-activated resin-based restorative material. Two formulations: Inlay (lower filler) and Onlay (higher filler, additional crosslinking monomer). Contains fluoride release agent. Supplied with water-soluble gel (Relief) for non-adhesion to liners. Biocompatibility tested per ISO 10993.

Indications for Use

Indicated for use as a temporary restorative material to protect prepared tooth surfaces during the interim period before permanent restoration placement in dental patients.

Regulatory Classification

Identification

A temporary crown and bridge resin is a device composed of a material, such as polymethylmethacrylate, intended to make a temporary prosthesis, such as a crown or bridge, for use until a permanent restoration is fabricated.

Predicate Devices

• Fermit (Vivadent)
• E-Z Temp (Cosmedent)
• Clip (Voco)

Submission Summary (Full Text)

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K963786
NOV 19 1996
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# 510 ( k ) Summary

## Statement of Safety and Effectiveness

## Kerr TempFil F Temporary Restorative Material

### BACKGROUND

Provisional or temporary restorative materials are used in dentistry for treatment procedures not intended to be permanent or final. The purpose of the temporary material is to protect a prepared tooth surface during the interim period until the permanent restoration is available. An example of this interim period is the time that passes while porcelain or metal prosthetic devices are being fabricated in a dental laboratory. Another purpose of a temporary restoration is to provide an esthetically pleasing appearance for the patient during this interim period.

### TEMPFIL F

Kerr’s TempFil F is designed to fulfill all of the requirements of a successful temporary restorative material. These requirements are itemized below:

1. Ease of placement. TempFil F is supplied in two formulations identified as Inlay and Onlay. The Inlay formula is slightly less filled and this lower viscosity paste will flow easily into the complex preparation configurations of the typical inlay type restoration. Conversely, the onlay formula, with its’ higher filler loading, results in a stiffer paste more suited to the sculpting and packing associated with a typical onlay type restoration.

2. These two formulations have also been adjusted to accommodate the different service conditions experienced by the two distinct types of restoration in the oral environment. The onlay paste contains an additional crosslinking monomer not found in the inlay material. This additional crosslinking results in a harder surfaced restoration which is better able to withstand forces exerted by opposing dentition. These forces are more prevalent in an onlay type restoration.

3. Convenience. The visible light activated curing characteristic of this no mix system is quicker and easier for the dentist to accomplish than the traditional chemically cured mixed catalyst and base systems.

4. Ease of removal. Both formulations contain a monomeric component that allows the cured material to maintain the degree of elasticity required for easy removal when the final restoration is available. This elasticity helps to prevent damage to prepared margins during removal.

5. Both formulations contain a fluoride release agent to impart the benefits of fluoride even during temporary use.

6. The kit contains a syringe of Relief, a water soluble gel that is designed to prevent adhesion to glass ionomer and composite resin based liners placed under the TempFil F restorative.

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# SAFETY

The safety of Kerr TempFil F has been demonstrated by subjecting cured samples of the material to various types of biocompatibility tests as recommended in the ISO 10993 biocompatibility guidance standard. These tests were conducted by an independent laboratory which specializes in safety and toxicity evaluation. The tests include:

1. Ames Mutagenicity Assay
2. Cytotoxicity Study (Agarose Overlay)
3. Kligman Maximization Study (Tissue Sensitization)

# EFFICACY

Effectiveness or suitability to the intended purpose of Kerr TempFil F has been demonstrated by a combination of in-house testing and side by side test comparisons to predicate devices currently on the market. Results of this bench testing indicates that Kerr TempFil F Temporary Restorative Material performs as well or better than Fermit (Mfg. by Vivadent), E-Z Temp (Mfg. by Cosmedent), Clip (Mfg. by Voco), three predicate devices currently on the market

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