DVI CURING LIGHT

K043530 · Designs For Vision, Inc. · EBZ · Jan 25, 2005 · Dental

Device Facts

• Record ID: K043530
• Device Name: DVI CURING LIGHT
• Applicant: Designs For Vision, Inc.
• Product Code: EBZ · Dental
• Decision Date: Jan 25, 2005
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.6070
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The DVI Curing Light is a dental curing light that is intended for the photopolymerization of dental resins.

Device Story

DVI Curing Light is a handheld dental device used for photopolymerization of dental resins. It consists of a handpiece containing an LED light source, a curved fiber optic end tip, and a charging cradle. The device is operated by a dental professional in a clinical setting. The user positions the fiber optic tip near the dental material and initiates the curing process. The LED emits light in the 405-470 nm wavelength range to activate photo-initiators in the resin. The device is powered by an internal battery charged via the cradle connected to an AC outlet. By hardening dental resins, the device facilitates restorative dental procedures. Accessories include a protective light-shield.

Clinical Evidence

No clinical data. Bench testing only. Testing included software and hardware verification and validation, electrical safety, electromagnetic compatibility, and resin polymerization time verification.

Technological Characteristics

LED-based light source; 405-470 nm wavelength range; handpiece with fiber optic tip; charging cradle; AC power source; software/hardware verification performed.

Indications for Use

Indicated for the photopolymerization of dental resins in a dental clinical 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

• Dentsply SmartLite (IQ) LED Curing Light (K041372)
• Sybron Dental L.E. Demetron (K021797)

Submission Summary (Full Text)

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K043530

JAN 2 5 2005

# 510(k) Summary for Designs for Vision Inc. Curing Light

#### 1. SPONSOR

Designs for Vision, Inc. 760 Koehler Avenue Ronkonkoma, NY 11779

Contact Person: Richard Feinbloom Telephone: [phone]

Date Prepared: December 20, 2004

#### 2. Device Name

Proprietary Name: DVI Curing Light Common/Usual Name: dental curing light ultraviolet activator for polymerization Classification Name:

#### 3. PREDICATE DEVICES

Dentsply SmartLite (IQ) LED Curing Light (K041372)

Sybron Dental L.E. Demetron (K021797).

#### 4. DEVICE DESCRIPTION

The DVI Curing Light consists of three major components; a handpiece, curved fiber optic end tip, and cradle. The handpiece contains the LED light source and a fiber optic light guide that directs light to the treatment area on the patient. The handpiece is placed in a cradle, which is connected via a plug-in transformer to an AC outlet for charging. A Protective light-shield and Fiber-optic end-tips are accessories provided with the DVI Curing Light, which support the operation and maintenance of the device.

The DVI curing light initiates curing (polymerization) of materials that are activated by photo initiators with an absorption in the wavelength range of

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between 405 to 470 nm. It is recommended that materials manufacturer's directions be followed for curing times. It is recommended that curing times be extended when curing through the tooth structure or when the distance from the curing light end tip to the material exceeds 3 mm.

#### ડ. INTENDED USE

The DVI Curing Light is a dental curing light that is intended for the photopolymerization of dental resins.

#### TECHNOLOGICAL CHARACTERISTICS AND SUBSTANTIAL EQUIVALENCE 6.

The proposed and predicate devices consist of a handpiece with a fiberoptic tip. The handpiece of the proposed DVI Curing Light and the predicate devices sit in a cradle. The handpiece is removed from the cradle during operation. The cradles of both the proposed and predicate devices serve as a charging base for the handpieces.

The operational principles of the proposed and predicate devices are identical in that they are LED devices used for photopolymerization of dental resins. The tip of the handpiece is oriented appropriately relative to the material being photopolymerized and the selected treatment time is initiated. In all devices, the light source is an LED light source located in the handpiece.

#### 7. PERFORMANCE TESTING

The following testing was conducted to evaluate the functional performance and safety of the proposed DVI Curing Light:

- Software and hardware verification and validation .
- . Electrical safety and electromagnetic compatibility
- . Resin polymerization times

The test results confirm that the proposed DVI Curing Light is safe and effective for use as a curing light.

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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is circular and contains the department's name around the perimeter. Inside the circle is an abstract symbol that resembles an eagle or bird in flight. The logo is black and white.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JAN 2 5 2005

Designs for Vision, Incorporated C/O Mary McNamara-Cullinane, RAC Staff Consultant Medical Device Consultants, Incorporated 49 Plain Street North Attleboro, Massachusetts 02760

Re: K043530

Trade/Device Name: DVI Curing Light Regulation Number: 21 CFR 872.6070 Regulation Name: Ultraviolet Activator for Polymerization Regulatory Class: II Product Code: EBZ Dated: December 20, 2004 Received: December 21, 2004

Dear Ms. McNamara-Cullinane:

We have reviewed your Section 510(k) premarket notification of intent to market the indication We have reviewed your Section 510(x) prematics is substantially equivalent (for the indications for referenced above and nave determined the devices marketed in interstate commerce
use stated in the enclosure) to legally market of predicate or to devices that use stated in the enclosure) to regally man keep preadinents, or to devices that prior to May 28, 1976, the enachient with the provisions of the Federal Food, Drug, and Cosmetic
have been reclassified in accordance with the provisions of the Features (PMA have been reclassified in accordance with the provisions of the Act. The may, a Act (Act) that do not require approval of a promatico provisions of the Act. The general therefore, market the device, subject to me general registration, listing of devices, good
controls provisions of the Act include requirements for annual regular and adultera controls provisions of the Act merace requiritions against misbranding and adulteration.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it If your device is classified (see above) more in the regulations affecting your device can be
may be subject to such additional controls. Existing may of anddition, EDA may p may be subject to such additions, Title 21, Parts 800 to 898. In addition, FDA may publish found in the Code of Featur reserving your device in the Federal Register.

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### Page 2 - Mary McNamara-Cullinane, RAC

Please be advised that FDA's issuance of a substantial equivalence determination does not mean Please be advised that I DX 3 Issualled of a volence complies with other requirements of the Act or that FDA nas made a determination and regulations and reactions. You must comply with CEP Page of C ally redular statutes and regulations abut not limited to: registration and listing (21 CFR Part 807); all the Act s requirements; morading, base manufacturing practice requirements as set forth in the quality labeling (21 CFR Part 807), good bart 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) I mis icher with anow you to begin mailing of substantial equivalence of your device to a legally premaired notification: "The PDF interior 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 If you desire specific admission 900 [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small general information on your of your er Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html

Sincerely yours,

Clive S. Liu, Ph.D.

Chiu S. Lin, PhD 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

1043530 510(k) Number (if known):

Device Name: _________________________________________________________________________________________________________________________________________________________________ DVI Curing Light

Indications for Use:

The DVI Curing Light is a dental curing light that is intended for photopolymerization of dental resins.

Prescription Use X (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)

Sina Runner

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

K(k) Number: K0413530

Designs for Vision, Inc. 510(k) Curing Light

December 20, 2004