BISCO LED

K052122 · Bisco, Inc. · EBZ · Mar 29, 2006 · Dental

Device Facts

• Record ID: K052122
• Device Name: BISCO LED
• Applicant: Bisco, Inc.
• Product Code: EBZ · Dental
• Decision Date: Mar 29, 2006
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.6070
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

Bisco LED, a visible-light dental curing device, is intended to provide the visible light required for polymerizing photo-initiated restorative materials used in dental practice.

Device Story

Bisco LED is a battery-powered, handheld dental curing light. It utilizes dual-peak wavelength LEDs (blue and purple) to emit visible light. The device features variable time settings, allowing clinicians to select specific curing durations and wavelengths. It is used in dental clinics by dental professionals to polymerize photo-initiated restorative materials. The device provides the necessary light energy to harden dental composites and adhesives, facilitating restorative procedures. It serves as a single-unit alternative to multi-unit systems that require separate devices for different wavelengths.

Clinical Evidence

No clinical data; bench testing only.

Technological Characteristics

Handheld, battery-powered dental curing light. Emits visible light via dual-peak (blue and purple) LEDs. Features variable time and wavelength selection. Class II device (21 CFR 872.6070).

Indications for Use

Indicated for use as a dental curing light to polymerize photo-initiated restorative materials in a dental practice setting.

Regulatory Classification

Identification

An ultraviolet activator for polymerization is a device that produces ultraviolet radiation intended to polymerize (set) resinous dental pit and fissure sealants or restorative materials by transmission of light through a rod.

Predicate Devices

• TRANSCURE, MODEL 2910 (K022862)

Submission Summary (Full Text)

{0}------------------------------------------------

K052122

#### Section 5 MAR 2 9 2006 510 (k) SUMMARY

| Applicant: | Bisco, Inc.<br>1100 W. Irving Park Road<br>Schaumburg IL, 60193 |
|-----------------|------------------------------------------------------------------|
| Contact Person: | Benjamin Lichtenwalner<br>Tel: [phone]<br>Fax: [phone] |
| Date Prepared: | July 20, 2005 |
| Trade Name: | Bisco LED |
| Common Name: | Dental Curing Light |

| Trade Name: | BISCO LED |
|----------------------|----------------------------------------------------------------------------|
| Common Name: | Dental Curing Light |
| Classification/Name: | Activator, Ultraviolet, For Polymerization<br>Class II per 21 CFR 872.6070 |

#### Description of Applicant Device:

Cl

Bisco LED is a dual peak wavelength visible-light dental curing device, with built-in variable time settings allowing for a selection of time and wavelength.

## Intended uses of Applicant Device:

Bisco LED, a visible-light dental curing device, is intended to provide the visible light required for polymerizing photo-initiated restorative materials used in dental practice.

Predicate Devices: TRANSCURE, MODEL 2910 (K022862) dated October 18, 2002.

### Significant Performance Characteristics:

# Bisco LED to TRANSCURE

| Property | Bisco LED | TRANSCURE |
|---------------------|--------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------|
| Intended use | Dental Curing Light | Dental Curing Light |
| Physical Properties | One Battery Powered, Handheld<br>Unit containing both blue and<br>purple LED's | Two Battery Powered, Handheld<br>Units with one for the blue and<br>one for the purple LED's |
| | Mechanical Properties | Uses LED's to selectively output<br>either the blue or purple light. |

Side by side comparisons of Bisco LED to the predicate device TRANSCURE clearly demonstrates that the applicant device is substantially equivalent to the legally marketed device.

Page 5-1

{1}------------------------------------------------

Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized eagle with its wings spread, and the words "DEPARTMENT OF HEALTH AND HUMAN SERVICES. USA" are arranged in a circular pattern around the eagle. The logo is black and white.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MAR 2 9 2006

Mr. Benjamin Lichtenwalner Regulatory Affairs Coordinator Bisco, Incorporated 1100 West Irving Park Road Schaumburg, Illinois 60193

Re: K052122

Trade/Device Name: Bisco LED Regulation Number: 21 CFR 872.6070 Regulation Name: Ultraviolet activator for polymerization Regulatory Class: II Product Code: EBZ Dated: March 20, 2006 Received: March 21, 2006

Dear Mr. Lichtenwalner:

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.

{2}------------------------------------------------

Page 2 - Mr. Benjamin Lichtenwalner

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 (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), 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 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/industry/support/index.html.

Sincerely vours.

Chiu Lin, Ph.D.

Chiu Lin, Ph.D. Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

{3}------------------------------------------------

K052122

510 (k) Number (if known):

Device Name: Bisco LED

Indications for Use:

Bisco LED is a LED dental curing light.

Prescription Use ✔ (Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use (21 CFR 807 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Susan Burns

" Circus General Ho Cial =