SOFT DENTURE REBASING RESIN

K963736 · Sybron Dental Specialties, Inc. · EBI · Dec 4, 1996 · Dental

Device Facts

• Record ID: K963736
• Device Name: SOFT DENTURE REBASING RESIN
• Applicant: Sybron Dental Specialties, Inc.
• Product Code: EBI · Dental
• Decision Date: Dec 4, 1996
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.3760
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Kerr Resilient Denture Liner is intended to be used as a resilient liner for complete or partial dentures to distribute functional and non-functional stress more evenly, acting as a shock absorbing appliance due to its elastic nature.

Device Story

Kerr Resilient Denture Liner is a two-component polyvinylsiloxane resin-based paste system; supplied in 50 ml double-barrel cartridges. Used with Kerr Extruder Mixing Gun and disposable static mixing tips; components mix during extrusion. Applied by dental professionals to denture bases to create a gingivally characterized elastomer. Acts as a shock-absorbing layer to distribute stress; improves comfort for patients with ridge issues or bruxism. Material is non-permanent; requires removal and replacement when resilience degrades or fouling occurs. Benefits include reduced chronic soreness and improved denture function.

Clinical Evidence

Bench testing only. Biocompatibility testing performed per ISO 10993, including Ames Mutagenicity Assay, Cytotoxicity Study (Agarose Overlay), and Implantation Test (Tissue Sensitization). Effectiveness demonstrated via side-by-side bench comparisons against predicate devices (Molloplast-B and Coe Supersoft).

Technological Characteristics

Polyvinylsiloxane resin-based elastomer. Two-part paste system (catalyst and base). Supplied in 50 ml double-barrel cartridges. Applied via extruder gun with static mixing tips. Biocompatibility tested per ISO 10993.

Indications for Use

Indicated for denture-wearing patients with ridge atrophy, ridge resorption, bony undercuts, bruxing tendencies, congenital or acquired defects, xerostomia, or dentures opposing natural dentition.

Regulatory Classification

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.

Predicate Devices

• Prolastic (Young Dental)
• Molloplast-B (Buffalo Dental Mfg. Co.)
• Coe Supersoft

Submission Summary (Full Text)

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DEC - 4 1996
K963736
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# 510 ( k ) Summary

## Statement of Safety and 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 tendencies
- 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 environment 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 separately - 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.

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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:

1. Ames Mutagenicity Assay
2. Cytotoxicity Study (Agarose Overlay)
3. 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

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