TEMPFIL C&B

K964981 · Sybron Dental Specialties, Inc. · EBG · Feb 10, 1997 · Dental

Device Facts

• Record ID: K964981
• Device Name: TEMPFIL C&B
• Applicant: Sybron Dental Specialties, Inc.
• Product Code: EBG · Dental
• Decision Date: Feb 10, 1997
• 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 C&B is a temporary crown and bridge restorative material; supplied in double-barreled cartridges for use with standard 1:1 ratio cartridge dispensers. Dentist dispenses material directly into impression or crown form; automatic mixing tips eliminate manual spatulation. Used in dental clinics to protect prepared tooth surfaces and provide esthetics during interim periods before permanent restoration placement. Benefits include ease of placement and procedural convenience.

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). Efficacy demonstrated via in-house bench testing and side-by-side comparisons to predicate devices.

Technological Characteristics

Temporary crown and bridge resin material. Supplied in double-barreled cartridges for 1:1 ratio dispensing. Biocompatibility testing performed per ISO 10993 standards.

Indications for Use

Indicated for use as a temporary restorative material to protect prepared tooth surfaces and provide esthetic appearance during the interim period while permanent restorations are being fabricated.

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

• Luxatemp (DMG)
• Protemp Garant (ESPE)
• Integrity (L. D. Caulk)

Submission Summary (Full Text)

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K964981
FEB 10 1997
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# 510 ( k ) Summary

## Statement of Safety and Effectiveness

### Kerr TempFil C&B Temporary Restorative Material

**Submitter**

Sybron Dental Specialties Inc.
1717 West Collins Avenue
Orange, CA 92867
[phone] - Phone
[phone] - FAX
William R. Pike - Contact Person

**Device Name**

Trade Name: TempFil C&B
Common Name: Temporary Crown and Bridge Material
Classification Name: Crown and Bridge Temporary, resin, per 21 CFR 872.3770

**Devices for which Substantial Equivalence is Claimed**

Luxatemp ( DMG ), Protemp Garant ( ESPE ), and Integrity ( L. D. Caulk )

## 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 C&B

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 C&B is supplied in a double barreled cartridge container which can be used with any of the currently available cartridge dispensers ( i.e. Kerr’s Extrude mixer/extruder dispenser ) that will accept 1:1 mix ratio plungers. This allows the dentist to simultaneously mix and dispense the material directly into the impression or crown form.

2. Convenience. The automatic mixing tips eliminate the need for spatulae, mixing pads and placement instruments.

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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 C&B Temporary Restorative Material performs as well or better than three predicate devices currently on the market

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