(63 days)
Not Found
Not Found
No
The device description and performance studies focus on the material properties and clinical performance of a dental cement, with no mention of AI or ML technologies.
No
The device is a temporary cement for dental procedures, which does not directly treat or prevent a disease, but rather facilitates a temporary restoration.
No
The device is a temporary cement for dental procedures, specifically designed for "temporary crown and bridge cementation procedures," which is a treatment function, not a diagnostic one.
No
The device description clearly describes a physical material (temporary cement) and its properties, not software.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is "for temporary crown and bridge cementation procedures." This is a dental procedure performed directly on a patient's teeth, not a test performed on a sample taken from the body.
- Device Description: The description focuses on the physical and chemical properties of the cement for its use in a dental setting (ease of placement, convenience, aesthetics, strength).
- Lack of IVD Characteristics: There is no mention of analyzing samples (blood, urine, tissue, etc.), detecting diseases, or providing diagnostic information based on biological markers.
This device is a dental material used for a restorative procedure, not a diagnostic test.
N/A
Intended Use / Indications for Use
Kerr Temp Bond Clear Temporary Cement is indicated for use for temporary crown and bridge cementation procedures.
Product codes (comma separated list FDA assigned to the subject device)
EMA
Device Description
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.
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Convenience. The chemical cure characteristics of Temp Bond Clear provide for a quick and simple procedure,
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Aesthetics. The highly translucent nature of Temp Bond Clear provides a pleasing, tooth-like appearance even when margins are exposed.
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Strength. The glass reinforced resin resists mastication forces that would fracture a ZOE type cement.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
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Indicated Patient Age Range
Not Found
Intended User / Care Setting
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Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
The safety 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 )
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 |
§ 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.
0
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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.
1
Page 2 of 2.
-
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 |