SCULPTING RESIN

K030585 · Bisco, Inc. · EBD · Apr 28, 2003 · Dental

Device Facts

• Record ID: K030585
• Device Name: SCULPTING RESIN
• Applicant: Bisco, Inc.
• Product Code: EBD · Dental
• Decision Date: Apr 28, 2003
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.3310
• Device Class: Class 2

Intended Use

The intended use of Bisco's Sculpting Resin is as a pre-wetting agent for placing and sculpting layers of composites and between layers of cured composite

Device Story

Sculpting Resin is a light-cured, low-viscosity, micro-filled (30% by weight) methacrylate resin. Used by dental professionals to reduce tackiness of composite materials during restorative procedures. Applied to instruments to improve handling and shaping of composite layers. Supplied in bottle or syringe delivery systems. Benefits include easier manipulation of composite materials, potentially improving clinical efficiency and restoration quality.

Clinical Evidence

Bench testing only; biocompatibility testing performed.

Technological Characteristics

Light-cured, low-viscosity, micro-filled (30% by weight) methacrylate resin. Supplied in bottle or syringe. No electronic components or software.

Indications for Use

Indicated for use as a pre-wetting agent to facilitate the placement and sculpting of composite dental materials.

Regulatory Classification

Identification

A coating material for resin fillings is a device intended to be applied to the surface of a restorative resin dental filling to attain a smooth, glaze-like finish on the surface of the filling.

Predicate Devices

• ULTRADENT COMPOSITE WETTING RESIN

Submission Summary (Full Text)

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APR 2 8 2003

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Section 6-1

Image /page/0/Picture/3 description: The image shows the logo for BISCO, a company specializing in adhesive and composite technology. The logo is made up of six hexagons, each containing a letter of the company name. The text "Specialist In Adhesive and Composite Technology" is written below the logo.

Reisemy Science !

Bisco, Inc. 1100 W. Irving Park Road, Schaumburg, II.. 60193 U.S.A. Telephone: [phone] or 1-800-BIS-DENT Fax: [phone] WEB SITE http://www.bisco.com

## Contact: Stephen D. Smith

# SUMMARY

This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of SMDA 190 and 21 CFR par 807.92

Trade Name: Common Name: Classification name:

SCULPTING RESIN Wetting Resin Material, Tooth Shade, Resin Class II per 21 CFR 872.3690

### Description of Applicant Device:

SCULPTING RESIN is a light-cured, low viscosity micro filled (30% by weight) resin formulation for use as a composite sculpting resin. It is supplied in a bottle and syringe. It is used on an instrument to reduce tackiness when shaping composites.

#### Intended uses of Applicant Device:

BISCO SCULPTING RESIN is for use as a composite wetting resin.

#### Predicate Devices: ULTRADENT COMPOSITE WETTING RESIN

#### Significant Performance Characteristics:

| | BISCO<br>SCULPTING RESIN | ULTRADENT<br>COMPOSITE WETTING RESIN |
|------------------------|-----------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------|
| Intended Use | Wetting resin. | Wetting resin. |
| Product<br>Description | Light-cured, low viscosity (30% filled), Methacrylates resin for use as a composite sculpting resin | Light cured, low viscosity (45% filled), Methacrylates resin used as a composite sculpting resin |
| Delivery<br>System | Bottle and syringe | Syringe |

Side by side comparisons of SCULPTING RESIN to the predicate device ULTRADENT COMPOSITE WETTING RESIN clearly demonstrates that the applicant device is substantially equivalent to the legally marketed devices. SCULPTING RESIN was tested for biocompatibility and was found to be non-toxic.

It is concluded that the information supplied in this submission has proven the safety and efficacy of SCULPTING RESIN.

Stephen D. Smith Manager Regulatory Affairs Telephone: [phone] Fax: [phone]

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Public Health Service

APR 2 8 2003

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Mr. Steve Smith Manager of Regulatory Affairs Bisco, Incorporated 1100 W. Irving Park Road Schaumburg, Illinois 60193

Re: K030585

Trade/Device Name: Sculpting Resin Regulation Number: 21 CFR 872.3310 Regulation Name: Coating Material for Resin Fillings Regulatory Class: II Product Code: EBD Dated: February 21, 2003 Received: February 24, 2003

Dear Mr. Smith:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and 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) that do not require approval of a premarket approval application (PMA). 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 (PMA), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

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Page 2 - Mr. Steve Smith

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), 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 Part 807.97) you may obtain. Other general 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 vours.

Suza Quaro

Susan Runner, DDS, MA Interim Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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of Sec. 2 Page 1

510(k) Number (if known):

036585

Device Name: Sculpting Resin

Indications For Use:

The intended use of Bisco's Sculpting Resin is as a pre-wetting agent for placing and sculpting layers of composites and between layers of cured composite

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

(Optional Format 3-10-98)

Kein Mulvey for MSA

(Division Sign-Off) (Division Sign-On)
Division of Anesthesiology, General Hospital, Intection Control, Dental Devi

510(k) Number: K030585