SLED CURING LIGHT SYSTEM

K031615 · Dentsply International · EBZ · Jul 21, 2003 · Dental

Device Facts

• Record ID: K031615
• Device Name: SLED CURING LIGHT SYSTEM
• Applicant: Dentsply International
• Product Code: EBZ · Dental
• Decision Date: Jul 21, 2003
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.6070
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

Curing camphorquinone-based visible light cured (VLC) materials.

Device Story

SLED CURING LIGHT SYSTEM is a cordless, battery-powered dental device for polymerizing VLC materials sensitive to 450-475 nm light. System comprises a handpiece with LED and control electronics, tapered fiber-optic probe, rechargeable battery, base unit, and transformer. Handpiece features a trigger switch for activation and mode switches for curing time/type settings. Used by dental professionals in clinical settings to deliver light to specific sites for material curing. Benefits include cordless operation and sustained power for dental restorative procedures.

Clinical Evidence

No clinical data provided; substantial equivalence is supported by performance data and comparison to legally marketed predicate devices.

Technological Characteristics

Cordless, battery-powered handpiece; LED light source (450-475 nm); tapered fiber-optic probe; base unit for charging and storage; control electronics for curing time/mode selection; user-serviceable battery compartment.

Indications for Use

Indicated for curing camphorquinone-based visible light cured (VLC) dental materials.

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

• Spectrum™ 800 Curing Unit (982318)
• Nova Cordless Light (000393)

Submission Summary (Full Text)

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Image /page/0/Picture/0 description: The image shows the word "DENTSPLY" in a bold, sans-serif font. Above the word, there is a handwritten number "K031615" in black ink. The number is written diagonally across the top left corner of the image.

# 510(k) SUMMARY

NAME & ADDRESS:

# JUL 2 1 2003

P. J. Lehn Telefax [phone]

P. Jeffery Lehn CONTACT:

May 22, 2003 DATE PREPARED:

TRADE OR PROPRIETARY NAME: SLED CURING LIGHT SYSTEM visible light cure for polymerization CLASSIFICATION NAME:

| | PREDICATE DEVICES: Spectrum™ 800 Curing Unit | 982318 |
|--|-------------------------------------------------------|--------|
| | Nova Cordless Light | 000393 |

## DEVICE DESCRIPTION:

The SLED CURING LIGHT is a cordless battery-powered unit designed for curing VLC materials whose initiators are sensitive to light in the 450-475 nm wavelength region of the visible spectrum. The light is based on LED (light emitting diodes) technology for light generation.

The SLED CURING LIGHT SYSTEM includes:

- . Handpiece with an LED and control electronics
- Tapered fiber-optic probe to deliver the light to a well-defined site .
- Battery for sustained electronic power ●
- . Base unit - charges battery
- stores handpiece when not in use
- Transformer to supply wall power to the base unit ●
- Optional amber-colored eye shield .

The SLED CURING LIGHT handpiece contains three switches: one trigger to turn the curing LED on and off and two mode switches to cycle the curing time and type through several different settings. The battery in the handpiece is contained in a user-serviceable compartment.

**DENTSPLY International**
570 West College Avenue
P.O. Box 872
York, PA 17405-0872
[phone]
Fax [phone]

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# 510(k) SUMMARY (cont'd.)

. "

#### INTENDED USE:

. . .

Curing camphorquinone-based visible light cured (VLC) materials.

1. 1. 1. 1.

#### TECHNOLOGICAL CHARACTERISTICS:

The SLED CURING LIGHT SYSTEM is substantially equivalent to K982318 in intended use, appearance and design, including source placement, probe style, on-board radiometer, control circuit, handpiece style.

The SLED CURING LIGHT SYSTEM is substantially equivalent to K000393 in intended use, operation, including the range of light emitted, curing time, and cooling.

We believe the similarity of the SLED CURING LIGHT SYSTEM to the legally marketed predicate devices and the performance data provided support the safety and effectiveness of the SLED CURING LIGHT SYSTEM for the indicated use.

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Image /page/2/Picture/1 description: The image shows a seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" written around the edge. In the center of the seal is an image of an eagle with its wings spread. The eagle is facing to the right and has three stripes on its chest.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JUL 2 1 2003

Mr. P. Jeffery Lehn Director of Corporate Compliance and Regulatory Affairs DENTSPLY International 570 West College Avenue P.O. Box 872 17405- 0872 York, Pennsylvania

Re: K031615

Trade/Device Name: SLED CURING LIGHT SYSTEM Regulation Number: 872. 6070 Regulation Name: Ultraviolet Activator for Polymerization Regulatory Class: II Product Code: EBT Dated: May 22, 2003 Received: May 27, 2003

Dear Mr. Lehn:

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. Lehn

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/dsma/dsmamain.html

Sincerely yours,

fothun

Susan Runner, DDDS, 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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## INDICATIONS FOR USE STATEMENT

(As Required by 21 CFR 807.87(e)

510(K) Number (if known): K031615

Device Name:

SLED CURING LIGHT SYSTEM

Indications for Use:

Curing camphorquinone-based visible light cured (VLC) materials.

RS Betz DDS for Dr. K. Mulry

(Division Sign-Off)
Division of Anesthesiology, General Hospital,
Infection Control, Dental Devices

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use

OR

510(k) Number

Over-The-Counter Use

(Per 21 CFR 801.109)

(Optional Format 1-2-96)

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