BISFIL 2B

K964000 · Bisco, Inc. · KLE · Nov 5, 1996 · Dental

Device Facts

• Record ID: K964000
• Device Name: BISFIL 2B
• Applicant: Bisco, Inc.
• Product Code: KLE · Dental
• Decision Date: Nov 5, 1996
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.3200
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

BISFIL 2B is indicated for use as a base increment posterior composite. It is intended to be used with ALL-BOND 2® or ONE-STEP™, or similar universal dental adhesive system. BISFIL 2B will bond to the enamel / dentin bonding system such as ONE-STEP. BISFIL 2B is intended to be covered by a high quality light-cure composite.

Device Story

BISFIL 2B is a self-cured, radiopaque, syringable composite resin used as a base increment in posterior dental restorations. Designed for the 'directed shrinkage' technique, the material utilizes the warmth of the tooth to initiate polymerization at the tooth-composite interface, directing shrinkage toward the tooth to minimize marginal gaps. The device is applied by a dentist in a clinical setting, typically followed by an overlay of a condensable light-cure composite. By remaining in a fluid state longer than light-cure materials, it allows for stress relaxation during curing, potentially reducing post-operative sensitivity and cusp fracture risks associated with polymerization shrinkage.

Clinical Evidence

Bench testing only. Performance characterized via diametral tensile testing and flexural modulus testing in accordance with ISO 4049 and American Dental Association Specification #27. No clinical trials were conducted; the directed shrinkage hypothesis is supported by cited dental research literature.

Technological Characteristics

Self-cured, silica and glass-filled dimethacrylate composite. Syringable, low-viscosity paste. Designed for chemical bonding to enamel/dentin via universal adhesive systems. Tested per ISO 4049 and ADA Specification #27.

Indications for Use

Indicated for use as a base increment posterior composite in patients requiring dental restorations. Used in conjunction with universal dental adhesive systems and overlaid with light-cure posterior composites.

Regulatory Classification

Identification

A resin tooth bonding agent is a device material, such as methylmethacrylate, intended to be painted on the interior of a prepared cavity of a tooth to improve retention of a restoration, such as a filling.

Predicate Devices

• BISFIL™ II

Reference Devices

• ALL-BOND® 2
• ONE-STEP™
• AELITEFIL™
• BISFIL P™

Submission Summary (Full Text)

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K964000

BISCO, INC., 1500 W. Thorndale Ave., Itasca, IL 60143
510(k) submission for BISFIL™ 2B

NOV - 5 1996

# 510(k) SUMMARY

As Required by the Safe Medical Devices Act of 1990

# IDENTIFICATION OF THE LEGALLY MARKETED PREDICATE DEVICE

## PREDICATE DEVICE

BISFIL™ II

BISFIL II is a self-cured, highly filled, radiopaque composite recommended for posterior restorations. The high filler concentration in BISFIL II (80%) results in improved abrasion resistance as well as high tensile and compressive strength. These properties are essential for composites to function effectively in the posterior segments. Optimum results require that BISFIL II be used in conjunction with a high quality dentin-enamel adhesive system such as ALL-BOND® 2 or ONE-STEP™.

Leading clinicians (Dr. John Kanca, Middlebury, CT) have recommend that BISFIL II be used as the base increment, to replace dentin, underneath a light - cure restorative in the "directed shrinkage" technique. Being self - cured, BISFIL II tends to cure towards the warmth of the tooth, rather than towards a light source, to prevent development of a marginal gap.

## DESCRIPTION OF THE APPLICANT COMPOSITE

BISFIL 2B (directed shrinkage composite) is a self-cure, base increment, radiopaque composite recommended for the "directed shrinkage" posterior composite technique suggested by Dr. Raymond Bertolotti.

BISFIL 2B begins curing adjacent to the naturally warmer surfaces of the dentin in the directed shrinkage technique. This is in contrast to light-cure composites which tend to begin curing towards the light source. Since all composites shrink on curing, the net effect of the directed shrinkage technique is to direct polymerization toward the tooth to help prevent formation of a marginal gap.

BISFIL 2B is a naturally sticky, syringable composite that is intended to be overlaid with a condensable light-cure posterior composite such as AELITEFIL™ or BISFIL P™. BISFIL 2B is intended to be used with ALL-BOND 2® or ONE-STEP™, or similar universal dental adhesive system.

## INTENDED USES OF APPLICANT COMPOSITE

BISFIL 2B is indicated for use as a base increment posterior composite. It is intended to be used with ALL-BOND 2® or ONE-STEP™, or similar universal dental adhesive system. BISFIL 2B will bond to the enamel / dentin bonding system such as ONE-STEP. BISFIL 2B is intended to be covered by a high quality light-cure composite.

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BISCO, INC., 1500 W. Thorndale Ave., Itasca, IL 60143
510(k) submission for BISFIL™ 2B

# SCIENTIFIC CONCEPTS and SIGNIFICANT PERFORMANCE CHARACTERISTICS

There has been a great deal of discussion in the dental research literature over the effect of polymerization shrinkage on the quality of a dental restoration. On the one hand, older systems did not bond to tooth structure so shrinkage simply resulted in gap formation between the tooth and restoration resulting in leakage and recurrent caries. Modern materials, on the other hand, bond well to tooth structure. During shrinkage, pain may occur due to stress placed on the tooth, a cusp may actually fracture because of the stress, or the bond may break resulting in leakage.

In the absence of a true non-shrinking composite, several tricks have been used to reduce or overcome the effects of polymerization shrinkage. One of these is the "directed shrinkage technique" propose by Dr. Raymond Bertolotti (see references). Bertolotti proposed that a self-cure composite will produce less shrinkage stress because, during curing, the stress is relaxed in the presence of uncured material. As the material cures more of the paste is converted to solid until such time as no fluid phase is present to accommodate the shrinkage, at which time the stress accumulates quickly. Conversely, a light-cure composite cures very quickly and there is very little time for the paste to accommodate shrinkage.

BISFIL 2B overcomes the above problems because of its higher resin content and its ability to flow while in the paste/fluid state during the early stages of curing. In addition, Dr. Bertolotti hypothesized that the warmer surface of the tooth will tend to polymerize the material in contact with it. This effectively causes shrinkage to occur toward rather that away from the tooth as might occur with a light-cure material. This hypothesis has been tested by Garberoglio (see References, #7) and others and found plausible.

The chemical composition of BISFIL 2B and BISFIL II are very similar. Both are silica and glass filled dimethacrylate composites. The resin compositions of both products are nearly identical with BISFIL 2B having somewhat less filler and lower viscosity.

The non-clinical tests used for this submission are similar to those specified in ISO 4049 and American Dental Association Specification #27. Diametral tensile testing is an accepted method to characterize the tensile strength of relatively brittle materials and the flexural modulus has become important recently in characterizing the strength in three point loading.

James L. Sandrik, PhD
BISCO, INC.
Itasca, IL 60143

October 4, 1996