(63 days)
Kerr Temp Bond Clear Temporary Cement is indicated for use for temporary crown and bridge cementation procedures.
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.
- Ease of placement. Kerr Temp Bond Clear handles very similarly to the ZOE cements alresdy familiar to dentists.
- Convenience. The chemical cure characteristics of Temp Bond Clear provide for a quick and simple procedure,
- Aesthetics. The highly translucent nature of Temp Bond Clear provides a pleasing, tooth-like appearance even when margins are exposed.
- Strength. The glass reinforced resin resists mastication forces that would fracture a ZOE type cement.
Here's an analysis of the provided text regarding the acceptance criteria and study for Kerr Temp Bond Clear Temporary Cement:
1. Table of Acceptance Criteria and Reported Device Performance
The document defines "efficacy" as "suitability to the intended purpose," which is demonstrated by a combination of in-house testing and side-by-side comparisons to predicate devices. The acceptance criteria are implicitly set by the performance of predicate devices already on the market (Temp Bond ZOE in this case), with the goal of performing "as well or better."
| Acceptance Criteria (Implicit, based on Predicate Device Performance) | Reported Device Performance (Temp Bond Clear) |
|---|---|
| Diametral Tensile Strength @ 24 hr. | 4285 psi (Better than Temp Bond ZOE) |
| Water Solubility | 0.5 % (Better than Temp Bond ZOE) |
| Film Thickness | < 25 microns (Meets Temp Bond ZOE) |
| Fluoride Release Rate | 10 ... µg/cm²/day (Better than Temp Bond ZOE as ZOE has 0) |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: Not explicitly stated. The document refers to "cured samples" for biocompatibility and "bench testing" and "comparison" for efficacy.
- Data Provenance: The biocompatibility tests were conducted by an "independent laboratory," and efficacy tests were "in-house testing." No country of origin is specified, but the submission is to the US FDA. The studies appear to be prospective (bench testing conducted for the purpose of this submission).
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
- Number of Experts: Not applicable. The "ground truth" for the performance characteristics (e.g., tensile strength, water solubility) is established through standardized material testing methods, not expert consensus.
- Qualifications of Experts: N/A.
4. Adjudication Method for the Test Set
- Adjudication Method: Not applicable. The data presented is quantitative performance data from material testing, not subjective assessments requiring adjudication.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done
- MRMC Study: No, an MRMC comparative effectiveness study was not done. This type of study typically involves human readers assessing diagnostic images or clinical scenarios, which is not relevant for a dental cement.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Standalone Performance: Not applicable. This device is a dental cement, not a software algorithm. The "standalone" performance refers to its physical and chemical properties and how it functions as a material. The provided data reflects the inherent properties of the material itself in laboratory settings.
7. The Type of Ground Truth Used
- Type of Ground Truth: The ground truth for the efficacy evaluation is based on objective, quantifiable material properties determined through standardized laboratory testing (e.g., diametral tensile strength, water solubility, film thickness, fluoride release rate). The "ground truth" for comparison is the performance of predicate devices in the market, which themselves have established performance characteristics.
8. The Sample Size for the Training Set
- Sample Size for Training Set: Not applicable. This refers to a medical device's physical/chemical properties study, not an AI/ML model that would have a training set.
9. How the Ground Truth for the Training Set was Established
- Ground Truth for Training Set: Not applicable, as there is no training set for an AI/ML model for this dental cement.
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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 (714) 516-7486 - Phone (714) 516-7488 - 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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Ease of placement. Kerr Temp Bond Clear handles very similarly to the ZOE cements alresdy familiar to dentists.
-
Convenience. The chemical cure characteristics of Temp Bond Clear provide for a quick and simple procedure,
-
Aesthetics. The highly translucent nature of Temp Bond Clear provides a pleasing, tooth-like appearance even when margins are exposed.
-
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:
-
- Ames Mutagenicity Assay
-
- 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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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 (301) 594-4618. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. 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 (800) 638-2041 or (301) 443-6597 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)
§ 872.3275 Dental cement.
(a)
Zinc oxide-eugenol —(1)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.(2)
Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 872.9.(b)
Dental cement other than zinc oxide-eugenol —(1)Identification. 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.(2)
Classification. Class II.