TEMP BOND CLEAR

K972844 · Kerr Dental Materials Center · EMA · Oct 3, 1997 · Dental

Device Facts

• Record ID: K972844
• Device Name: TEMP BOND CLEAR
• Applicant: Kerr Dental Materials Center
• Product Code: EMA · Dental
• Decision Date: Oct 3, 1997
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.3275
• Device Class: Class 2

Intended Use

Kerr Temp Bond Clear Temporary Cement is indicated for use for temporary crown and bridge cementation procedures.

Device Story

Temp Bond Clear is a glass-reinforced, resin-based temporary dental cement. It is used by dentists in clinical settings to secure temporary crowns and bridges during the interim period while permanent restorations are fabricated. The material is applied to the temporary restoration, which is then placed on the prepared tooth surface. It provides mechanical retention to withstand mastication forces while allowing for easy removal when the permanent appliance is ready. Its translucent nature provides an esthetic, tooth-like appearance. The device benefits patients by protecting prepared tooth surfaces and maintaining esthetics during the restorative process.

Clinical Evidence

Bench testing only. Comparison of physical properties between Temp Bond Clear and Temp Bond (ZOE) demonstrated: Diametral Tensile Strength (4285 psi vs 280 psi), Water Solubility (0.5% vs 2.5%), Film Thickness (<25 microns for both), and Fluoride Release (10 µg/cm²/day vs 0). Biocompatibility testing included Ames Mutagenicity Assay and Cytotoxicity Study (Agarose Overlay) per ISO 10993.

Technological Characteristics

Glass-reinforced resin-based dental cement. Chemical cure mechanism. Translucent appearance. Formulated for temporary cementation. Biocompatibility tested per ISO 10993.

Indications for Use

Indicated for temporary cementation of dental crowns and bridges in patients requiring provisional restorative treatment.

Regulatory Classification

Identification

Zinc oxide-eugenol is a device composed of zinc oxide-eugenol intended to serve as a temporary tooth filling or as a base cement to affix a temporary tooth filling, to affix dental devices such as crowns or bridges, or to be applied to a tooth to protect the tooth pulp. Dental cement other than zinc oxide-eugenol is a device composed of various materials other than zinc oxide-eugenol intended to serve as a temporary tooth filling or as a base cement to affix a temporary tooth filling, to affix dental devices such as crowns or bridges, or to be applied to a tooth to protect the tooth pulp.

Predicate Devices

• Temp Bond (K972844)
• Temp Bond NE (Non Eugenol) (K972844)
• Resiment Resin Based Temporary Cement (K972844)

Submission Summary (Full Text)

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K972844

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# 510 ( k ) Summary

## Statement of Safety an Effectiveness

#### Kerr Temp Bond Clear Temporary Cement

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: Temp Bond Clear Common Name: Temporary Crown and Bridge Cement Classification Name; Dental Cement Other than Zinc Oxide - Eugenol 76 EMA 2 ( 21 CFR 872.3275 )

#### Devices for which Substantial Equivalence is Claimed

Temp Bond and Tcmp Bond NE ( Non Eugenol ) : Manufactured by Kerr Corporation Resiment Resin Based Temporary Cement : Marketed by Septodont Corp.

## 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 matcrial is to protect a prepared toolh 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. It is necessary to attach the lemporary device with a coment that is durable enough to withstand forces encountered in the oral environment vel is casily removed when the permanent appliance becomes available. Zinc Oxide/Eugenol ( ZOE ) type coments have been the most popular with dentists in the pass for this application, however, with the advent advanced resin-based restorative materials a resin- based, glass reinforced cement has been developed to overcome the shoricomings of the ZOE cements.

## TEMP BOND CLEAR TEMPORARY CEMENT

Kerr's Temp Bond Clear is designed to fulfill all of the requirements of a successful temporary restorative cementation material. These requirements are itemized below.

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1. Ease of placement. Kerr Temp Bond Clear handles very similarly to the ZOE cements alresdy familiar to dentists.

2. Convenience. The chemical cure characteristics of Temp Bond Clear provide for a quick and simple procedure,

3. Aesthetics. The highly translucent nature of Temp Bond Clear provides a pleasing, tooth-like appearance even when margins are exposed.

4. Strength. The glass reinforced resin resists mastication forces that would fracture a ZOE type cement.

# SAFETY

The salety of Kerr Temp Bond Clear 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 loxicity evaluation. The tests include:

- 1. Ames Mutagenicity Assay
- 2. Cytotoxicity Study ( Agarose Overlay )

# EFFICACY

Effectiveness or suitability to the intended purpose of Kerr Temp Bond Clear 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 Temp Bond Clear Temporary Cement performs as well or better than prodicale devices currently on the market. An demonstration of this fact is presented in the comparison of Temp Bond Clear with Temp Bond ( ZOE ) below,

| PROPERTY | Temp Bond Clear | Temp Bond (ZOE) |
|-------------------------------------|-------------------|-----------------|
| Diametral Tensile Strength @ 24 hr. | 4285 psi | 280 psi |
| Water Solubility | 0.5 % | 2.5 % |
| Film Thickness | < 25 microns | < 25 microns |
| Fluoride Release Rate | 10 ... µg/cm²/day | 0 |

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Image /page/2/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an image of an eagle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20856

OCT - 3 1997

Mr. William R. Pike Regulatory Affairs Specialist Kerr Dental Materials Center 1717 West Collins Avenue Orange, California 92667

K972844 Re : Temp Bond Clear Trade Name: Requlatory Class: II Product Code: EMA September 16, 1997 Dated: Received: September 22, 1997

Dear Mr. Pike:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.

If your device is classified (see above) into either class II (Special Controls) or class III (Premarket Approval), it may be subject to such additional controls. - Existing major requlations affecting your device can be found in the Code of Federal Requlations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirement, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic (QS) inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory In addition, FDA may publish further announcements action. concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic

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Page 2 - Mr. Pike

Product Radiation Control provisions, or other Federal laws or requlations.

This letter will allow you to begin marketing your device as described in your 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a leqally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling requlation (21 CFR Part 801 and additionally 809.10 for in vitro diaqnostic devices), please contact the Office of Compliance at [phone]. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number [phone] or [phone] or at its internet address "http://www.fda.qov/cdrh/dsmamain.html".

Sincerely yours,

Timothy A. Ulatowski

Timo Director Division of Dental, Infection Control and General Hospital Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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510(**k**) Number: K972844

Device Name : Kerr Temp Bond Clear Temporary Cement

Indications For Use : Kerr Temp Bond Clear Temporary Cement is indicated for use for temporary crown and bridge cementation procedures.

Susan Runner

(Division Sign-Off) (Division Sign-On)
Division of Dental, Infection Control, Divisional Hospital D 510(k) Number

Prescription Use -Prescription 801.109)