(65 days)
belleGlass HP, Concept, Art Glass
No
The device description focuses solely on material reformulation and does not mention any software, algorithms, or data processing related to AI/ML.
No.
The device is described as a reformulation of existing dentin pastes, used in dentistry. Dentin pastes are materials used for dental restorations, which are not considered therapeutic devices in the medical sense as they do not treat or cure a disease, but rather restore function or aesthetics. The "Intended Use / Indications for Use" section is "Not Found," but the "Device Description" strongly suggests a dental restorative material.
No
The device description indicates it is a reformulation of existing dental pastes for increased durability and stability, not a tool for diagnosing medical conditions.
No
The device description clearly describes a physical material (dentin paste) with chemical modifications, indicating it is a hardware/material-based medical device, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use/Indications for Use: This section is "Not Found," which is a key indicator for IVDs. IVDs are used to examine specimens from the human body to provide information for diagnosis, monitoring, or screening. The description of this device doesn't mention anything about analyzing biological samples.
- Device Description: The description details a dental material (dentin paste reformulation) used for increasing durability and stability in the mouth. This is a material applied to the body, not used to analyze samples from the body.
- Lack of IVD-specific information: The document lacks any mention of typical IVD characteristics such as:
- Analyzing biological specimens (blood, urine, tissue, etc.)
- Providing diagnostic information
- Mentioning specific analytes or biomarkers
The description clearly points to a dental restorative material, which falls under a different regulatory category than IVDs.
N/A
Intended Use / Indications for Use
Not Found
Product codes
Not Found
Device Description
Kerr's Foundation consists of a reformulation of the existing Opaceous Dentin Pastes in order to increase durability and material stability in the mouth. This reformulation consists essentially of two significant modifications: 1. The addition of 0.15 weight percent of VAZO 88 ( Azobiscyclohexane Carbonitrile ), a heat activated polymerization initiator. 2. The replacement by 56 weight percent of the Barium Alumnoborosilicate glass filler with a corresponding amount of Magnesium Aluminosilicate, a low coefficient of thermal expansion glass filler. This combination of initiator and glass filler modifications results in a compsite resin-based restorative material that exhibits half the thermal expansion characteristics of existing products and produces reductions in Volume % Polymerization Shrinkage in a range of 33 to 70 %.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
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
The safety of Kerr Foundation Indirect Restorative 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 ( Elution Test, USP 23 ) - 3. Kligman Maximization Study ( Tissue Sensitization ) - 4. Intramuscular Implantation Test ( Tissue Irritation ). Effectiveness or suitability to the intended purpose of Kerr Foundation has been demonstrated by a combination of in-house testing and side by side test comparisons to predicate devices currently on the market.
Key Metrics
Not Found
Predicate Device(s)
belleGlass HP ( Kerr Corp. ), Concept ( Williams Dental ), Art Glass ( Hereas Kulzer GmbH )
Reference Device(s)
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 872.3690 Tooth shade resin material.
(a)
Identification. Tooth shade resin material is a device composed of materials such as bisphenol-A glycidyl methacrylate (Bis-GMA) intended to restore carious lesions or structural defects in teeth.(b)
Classification. Class II.
0
APR 1 6 1997
K9 70495
Page 1 of 2
510 ( k ) Summary
Statement of Safety an Effectiveness
Kerr Foundation Indirect Composite Resin
Submitter
Sybron Dental Specialties Inc. 17 17 West Collins Avenue Orange CA 92867 (714) 516-7486 - Phone (714) 516-7488 - FAX William R. Pike - Contact Person
Device Name
Trade Name: Foundation Indirect Composite Resin Common Name:Dual cured indirect composite restorative material Classification Name: Tooth Shade Resin Material, Class II, per 21 CFR 872.3690
Devices for which Substantial Equivalence is Claimed
belleGlass HP ( Kerr Corp. ), Concept ( Williams Dental ), Art Glass ( Hereas Kulzer GmbH )
BACKGROUND
Kerr introduced a new composire resin based Crown and Bridge fabrication system called belleGlass HP in May, 1996 ( Reference K955331 ). This system is comprised of all of the components necessary for a dental laboratory to fabricate composite resin-based Crowns and Bridges and cure them using both light activation combined with a final heat and pressure curing cycle in the belleGlass HP automatic curing device. ( Complete existing Instructions for Use of this product is supplied elsewhere in this submission. ) One of the sets of composite materials used in this process is referred to as Opaceous Dentin Pastes. These consist of 16 light cured only pastes which match the Vita Shade Guide used with Vita Porcelain powders. These materials proved adequate, but because of their single cure mode ( visible light activation ) they may not be durable enough to withstand the constant abuse associated with long term residence in the oral environment. Therefore, a more durable, yet esthetically acceptable material was sought.
FOUNDATION INDIRECT COMPOSITE
Kerr's Foundation consists of a reformulation of the existing Opaceous Dentin Pastes in order to increase durability and material stability in the mouth. This reformulation consists essentially of two significant modifications:
- The addition of 0.15 weight percent of VAZO 88 ( Azobiscyclohexane Carbonitrile ), a heat activated polymerization initiator.
1
- The replacement by 56 weight percent of the Barium Alumnoborosilicate glass filler with a corresponding amount of Magnesium Aluminosilicate, a low coefficient of thermal expansion glass filler.
This combination of initiator and glass filler modifications results in a compsite resin-based restorative material that exhibits half the thermal expansion characteristics of existing products and produces reductions in Volume % Polymerization Shrinkage in a range of 33 to 70 %.
SAFETY
The safety of Kerr Foundation Indirect Restorative 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:
-
- Ames Mutagenicity Assay
-
- Cytotoxicity Study ( Elution Test, USP 23 )
-
- Kligman Maximization Study ( Tissue Sensitization )
-
- Intramuscular Implantation Test ( Tissue Irritation )
EFFICACY
Effectiveness or suitability to the intended purpose of Kerr Foundation 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 Foundation Indirect Composite performs as well or better than three predicate devices currently on the market
Results of this testing is included elsewhere in this submission.