(78 days)
I'm sorry, but without text input, I cannot identify any K/DEN numbers. Please provide the text.
No K/DEN numbers were found in the provided text.
No
The device description and performance studies focus on the material properties and biocompatibility of a denture liner, with no mention of AI or ML.
Yes
The device is a resilient liner used to treat various conditions in denture-wearing patients, indicating a therapeutic purpose to address and alleviate medical conditions.
No
The device description indicates it is a material used to line dentures, and its 'Intended Use' section lists conditions that it helps treat, rather than diagnose. Its purpose is therapeutic, not diagnostic.
No
The device description clearly states it consists of two paste components and is used with a mixing gun, indicating it is a physical material and hardware, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for treating denture-wearing patients with various oral conditions. This is a direct application within the oral cavity for therapeutic or prosthetic purposes.
- Device Description: The device is a material that polymerizes to form an elastomer for use as a denture liner. This is a physical material applied to a medical device (denture) for use within the body.
- Lack of Diagnostic Purpose: There is no mention of the device being used to diagnose a disease or condition, or to examine specimens derived from the human body.
- Biocompatibility and Performance Testing: The testing described focuses on the safety of the material in contact with tissue and its performance as a denture liner, not on its ability to detect or measure biological markers.
IVD devices are specifically designed to examine specimens from the human body (like blood, urine, tissue) to provide information for the diagnosis, monitoring, or treatment of a disease or condition. This device does not fit that description.
N/A
Not Found
§ 872.3760 Denture relining, repairing, or rebasing resin.
(a)
Identification. A denture relining, repairing, or rebasing resin is a device composed of materials such as methylmethacrylate, intended to reline a denture surface that contacts tissue, to repair a fractured denture, or to form a new denture base. This device is not available for over-the-counter (OTC) use.(b)
Classification. Class II.
0
DEC - 4 1996
Page 1 of 2
510 ( k ) Summary
Statement of Safety an Effectiveness
Kerr Resilient Denture Liner
BACKGROUND
The success of complete or partial dentures depends upon esthetics, comfort and function. Unfortunately, the high stress concentrations encountered during function can adversely affect the health of supporting tissues. Chronic soreness can be a significant problem for many denture patients. The problem results from the soft, denture bearing tissues being confined between the hard denture base and the hard bones of maxilla and mandible.
The use of Resilient Liners is an attempt to distribute the functional and non-functional stress more evenly with the Resilient Liner acting as a shock absorbing appliance due to their elastic nature.
Dentistry traditionally uses Resilient Liners to treat denture wearing patients with:
- Ridge atrophy Ridge resorption Bony undercuts Bruxing tendancies Congenital or acquired defects Xerstomia Dentures opposing natural dentition
In application, Resilient Liners fall into three chemical categories; plasticized polymers or copolymers, silicone rubbers and fluoroelastomers. All three classes were chosen due to their relative ease of manipulation and their ability to maintain resiliency over an extended time in the oral cavity. None of these classes can be considered permanent as they lose their resilience with time, become fouled by the oral envirinment or suffer bond failure from the hard denture base material. At this point the resilient material must be removed and replaced.
The Kerr Resilient Liner fits into the silicone category of products such as Prolastic ( Young Dental ) and Molloplast-B ( Buffalo Dental Mfg. Co. ) and is substantially equivalent to them with respect to safety and efficacy.
Kerr Resilient Denture Liner consists of two Polvinylsiloxane resin based paste components which interact and polymerize to produce a gingivally characterized elastomer. It is supplied in two 50 ml double barrel cartridges containing 25 ml. each of both the catalyst and base pastes. These cartridges are designed to be used with the Kerr Extruder Mixing Gun ( Sold seperately - Covered in 510 ( k ) No. K940379 ). The cartridges attach to disposable static mixing tips which mix the catalyst and base pastes by forces exerted by the Kerr Extruder prior to application of the soft liner material.
1
The safety of Kerr Resilient Denture Liner 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:
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- Ames Mutagenicity Assay
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- Cytotoxicity Study ( Agarose Overlay )
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- Implantation Test ( Tissue Sensitization )
Effectiveness or suitability to the intended purpose of Kerr Resilient Denture Liner 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 Resilient Denture Liner performs as well or better than Molloplast-B and Coe Supersoft, two predicate devices currently on the market