A-WEAR

K012180 · Bisco, Inc. · EBF · Sep 5, 2001 · Dental

Device Facts

• Record ID: K012180
• Device Name: A-WEAR
• Applicant: Bisco, Inc.
• Product Code: EBF · Dental
• Decision Date: Sep 5, 2001
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.3690
• Device Class: Class 2
• Attributes: Therapeutic

Indications for Use

A-Wear™ is intended for direct or indirect class III, IV, and V restorations and diastema closures. A-Wear™ is also intended for composite restorations bonded to tooth structure, metal, composite, fiber-reinforced substructure, and porcelain.

Device Story

A-Wear™ is a dental composite material designed for high wear/abrasion resistance and polishability. It is a translucent material (opacity <40%) cured via heat and light. Used by dentists in clinical settings for direct or indirect restorations (Class III, IV, V), diastema closures, and veneers. The material is applied to tooth structure or various substructures (metal, composite, fiber-reinforced, porcelain) using high-quality dentin/enamel adhesive systems. It functions as a restorative restorative material to replace lost tooth structure or improve aesthetics, directly impacting clinical decision-making by providing a durable, aesthetic solution for dental defects.

Clinical Evidence

Bench testing only.

Technological Characteristics

Translucent composite material (opacity <40%). Cured by heat and light. Designed for use with dentin/enamel adhesive systems.

Indications for Use

Indicated for patients requiring direct or indirect class III, IV, and V dental restorations, diastema closures, and veneers. Suitable for bonding to tooth structure, metal, composite, fiber-reinforced substructures, and porcelain.

Regulatory Classification

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.

Predicate Devices

• Micronew™

Submission Summary (Full Text)

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BISCO, INC., 1100 W. Irving Park Road, Schaumburg, IL 60193 510(k) Submission for A-Wear™

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K012180

#### SUMMARY

## Legally Marketed Predicate Device Micronew™

Micronew™ is a translucent composite designed to yield high resistance to wear and Microw - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - indirect or direct restorations.

## Description of Applicant Device A-Wear™

A-Wear™ provides the dentist with a composite designed to yield high resistance to wear and abrasion and excellent polishing characteristics. In addition to these properties, Aand ublighty translucent (opacity <40%). A- Wear™ is cured by heat and light and is designed to be used with high quality dentin/enamel adhesive systems.

### Intended Uses of Applicant Device A-Wear™

A-Wear™ is intended for direct or indirect class III, IV, and V restorations and diastema closures. A-Wear™ is also intended for composite restorations bonded to tooth structure, metal, composite, fiber-reinforced substructure, and porcelain.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of an eagle with three wing-like shapes, suggesting movement or flight. The logo is presented in black and white.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

# SEP - 5 2001

Mr. Steven J. Duray Mr. Beeven of Technical Business Support Services Bisco, Incorporated 1100 West Irving Park Road Schaumburg, Illinois 60193

Re : K012180 Trade/Device Name: A-Wear 872.3690 Requlation Number: Requlatory Class: II EBF Product Code: July 11, 2001 Dated: Received: July 12, 2001

Dear Mr. Duray:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.

If your device is classified (see above) into either class II (Special Controls) or class III (Premarket Approval), it may be subject to such additional controls. Existing major requlations affecting your device can be found in the Code of Title 21, Parts 800 to 895. ਸ Federal Regulations, substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements

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#### Paqe 2 - Mr. Duray

concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or requlations.

This letter will allow you to begin marketing your device as described in your 510 (k) premarket notification. The FDA deborizod in formalence of your device to a legally marketed predicate device results in a classification for your markets processor with your device to proceed to the market.

If you desire specific advice for your device on our labeling requlation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at [phone]. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 807.97). Other qeneral information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html.

Sincerely yours,

A. Ulatowski Timo Director

Division of Dental, Infection Control and General Hospital Devices Office of Device Evaluation Center for Devices and Radioloqical Health

Enclosure

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BISCO, INC., 1100 W. Irving Park Road, Schaumburg, IL 60193 510(k) Submission for A-Wear™

### INDICATIONS FOR USE

| 510(k) Number (if known): | K012180 |
|---------------------------|---------|
| Device Name: | A-Wear™ |

Indications for Use:

- 1. Direct or indirect class III, IV, and V restorations.
- Diastema closures. 2.
- 3. Composite restorations bonded to tooth structure.
- 4. Composite restorations bonded to metal.
- 5. Composite restorations bonded to composite or fiber-reinforced substructure.
- Composite restorations bonded to porcelain. ે.
- 7. Direct or indirect veneers.

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(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRL, Office of Device Evaluation (ODE)

| Prescription for Use | X | OR | Over-The-Counter Use |
|----------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----|--------------------------|
| (Per 21 CFR 801.109) | | | (Optional Format 1-2-96) |
| | <div> <img alt="Signature" src="signature.png"/> </div> (Division Sign-Off) Division of Dental, Infection Control, and General Hospital Devices 510(k) Number K02180 | | |