SIMPLE

K013519 · Bisco, Inc. · KLE · Jan 17, 2002 · Dental

Device Facts

• Record ID: K013519
• Device Name: SIMPLE
• Applicant: Bisco, Inc.
• Product Code: KLE · Dental
• Decision Date: Jan 17, 2002
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.3200
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

Direct and Indirect Restorations: to etch enamel/dentin prior to bonding with ONE ● STEP® for use with light-cured composite materials Indirect Restorations: when used with an adhesive, to seal a preparation when using a . light-cured composite cement Desensitization: when used in combination with adhesivo, to treat hypersensitive and/or 8 exposed root surfaces.

Device Story

SIMPLE is a two-bottle or unit-dose self-etching primer system used in dental clinics by practitioners. It functions as a chemical primer to etch enamel and dentin surfaces, preparing them for bonding with light-cured dental adhesives and composite materials. The device is applied to the tooth surface to facilitate adhesion for restorations or to treat root hypersensitivity. It serves as a preparatory step in restorative dentistry, enabling the subsequent application of light-cured composite materials or cements. The system is designed to reduce the number of clinical steps required for surface preparation compared to traditional etching methods.

Clinical Evidence

Bench testing only. Biocompatibility testing, including cytotoxicity and acute oral toxicity, was performed to demonstrate safety.

Technological Characteristics

Two-bottle or two-chamber unit dose delivery system. Consists of one clear yellow solution and one white slurry. Self-etching primer chemistry. Class II device per 21 CFR 872.3200.

Indications for Use

Indicated for patients requiring enamel/dentin etching prior to bonding with light-cured composite materials for direct/indirect restorations, sealing preparations for light-cured composite cements, and treatment of hypersensitive or exposed root surfaces.

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

• Clearfil™ SE BOND (K990040)

Submission Summary (Full Text)

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The station of the state of the contract and the same of the many of the comments of the comments of

JAN 1 7 2002

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Section 5-1

Image /page/0/Picture/4 description: The image shows the logo for BISCO, a company specializing in adhesive and composite technology. The logo consists of a series of interconnected hexagons, each containing a letter that spells out "BISCO". Below the logo, the text "Specialist In Adhesive and Composite Technology" is written in a smaller font. The logo is black and white and appears to be a scan of a printed document.

Bisco, Inc. 1100 W. Irving Park Road Schaumburg, Il 60193 Telephone: [phone] Fax: [phone] Contact: Stephen D. Smith, Regulatory Affairs Manager

Brenders Science as Virg

### 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:

No Rinse Self-Etching Primer Resin Tooth Bonding Agent Class II per 21 CFR 872.3200

Description of Applicant Device:

A two bottle (or unit dose container), no rinse self-etching primer for use with light cured dental adhesives.

SIMPLE

Intended uses of Applicant Device:

- Direct and Indirect Restorations: to etch enamel/dentin prior to bonding with ONE ● STEP® for use with light-cured composite materials
- Indirect Restorations: when used with an adhesive, to seal a preparation when using a . light-cured composite cement
- Desensitization: when used in combination with adhesivo, to treat hypersensitive and/or 8 exposed root surfaces.

Predicate Devices: Clearfil™ SE BOND K990040 (clearance date of 2/4/99)

## Siguificant Performance Characteristics:

| | SIMPLE | Clearfil SE BOND |
|-------------------------|--------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------|
| Intended Use: | Designed to reduce steps in<br>preparing dentin and enamel<br>for composite adhesion | Designed to reduce steps in<br>preparing dentin and enamel<br>for composite adhesion |
| Product<br>Description: | One clear yellow solution<br>One white slurry | Two clear solutions |
| Delivery<br>System: | Two solutions in separate<br>bottles or in a two-chamber<br>unit dose package. | Two solutions in separate<br>bottles package. |

Side by side comparisons of SIMPLE to the predicate device Clearfil SE BOND clearly demonstrates that the applicant device is substantially equivalent to the legally marketed devices. The ingredients of Simple were biocompatibility tested, cytotoxicity and acute oral toxicity, and were found to be non-toxic.

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

Stephen D. Smith Manager of Regulatory Affairs

Tel: 1-800-BISDENT or 847 534-6146 Fax: [phone]

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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 an abstract symbol resembling an eagle or bird in flight, composed of three curved lines representing the wings and a wavy line representing the body.

Public Health Service

JAN 1 7 2002

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Mr. Stephen D. Smtih Manager of Regulatory Affairs Bisco, Incorporated 1100 West Irving Park Road Schaumburg, Illinois 60193

Re: K013519

Trade/Device Name: Simple Regulation Number: 872.3200 Regulation Name: Resin Dentin Bonding System Regulatory Class: II Product Code: KLE Dated: October 17, 2001 Received: October 23, 2001

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.

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.

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Page 2 - Mr. Smith

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 (QS) 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 and additionally 21 CFR Part 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 Part 807.97). 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 yours

Timothy A. Ulatowski

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

Enclosure

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K013519 510(k) Number (if known):

Device Name: SIMPLE

ר

Indications For Use:

1. Direct and Indirect Restorations: to etch enamel/dentin prior to bonding with ONE-Step and some other fifth generation adhesives for use with light-cured composite materials

2. Indirect Restorations: when used with an adhesive, to seal a preparation when using a light-cured composite cement.

3. Densensitization: when used in combination with adhesive, to treat hypersensitive and/or exposed root surfaces.

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## Concurrence of CDRH, Office of Device Evaluation (ODE)

(Optional Format 3-10-98)

Susan Riisa

'Division Sign-Off) Division of Dental, Infection Control, ୍ General Hospital D - - General Hospital Devices - 013319