POWER LED

K033697 · Dental Products of USA, Inc. · EBZ · Feb 27, 2004 · Dental

Device Facts

• Record ID: K033697
• Device Name: POWER LED
• Applicant: Dental Products of USA, Inc.
• Product Code: EBZ · Dental
• Decision Date: Feb 27, 2004
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.6070
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The intended use of Power LED is to act as a polymerization source using visible light to cure composite resins.

Device Story

Power LED is a cordless dental curing light used to polymerize light-cured composite resins. The device consists of a handpiece with an LED light engine, a rechargeable battery pack, and a battery charger. A digital circuit on a printed circuit board controls four distinct curing modes, managing LED timing and audible beeps; a segmented display indicates the selected mode. The clinician activates the light via a pushbutton on the handpiece. Used in dental clinics, the device provides a portable light source for restorative procedures, allowing practitioners to harden dental materials efficiently.

Clinical Evidence

Bench testing only.

Technological Characteristics

Cordless handpiece with LED light engine; rechargeable battery pack; digital circuit on printed circuit board for mode control; segmented display; pushbutton activation; battery charger with status indicator lights.

Indications for Use

Indicated for the polymerization of visible light cured composite resins in dental applications.

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

• 3M ESPE AG, Elipar FreeLight
• I.E. Demertrone I

Submission Summary (Full Text)

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K033697

FEB 27 2004

Image /page/0/Picture/2 description: The image is a logo for Dental Products of USA, Inc. The logo features the letters "DP" in a bold, stylized font, with the words "DENTAL PRODUCTS" above the letters and "OF USA" below. The full name of the company, "Dental Products of USA, Inc.", is printed in a smaller font below the logo. The website address, www.dentalproductsofusa.com, is also printed below the logo.

February 13, 2004

Section III 510(k) Summary of Safety and Effectiveness

Submitter:

Dental Products of USA, Inc. 1460 NW 107 Ave Suite G Miami, Florida 33172 Phone : [phone] Facsimile: [phone] Contact Person: George Echeverri

October 2,2003-February 13, 2004 Summary Prepared Date:

## Device Name:

- Trade Name Bellini International I.
- Common Name Power LED II.
- Classification Name Ultraviolet activator for polymerization, per 21 CFR § 872.6070 ///

### Device for Which Substantial Equivalence is Claimes:

- 3M ESPF. AG, Elipar FreeLight, I.E. Demertrone I.
#### Device Description:

The Power LED Cordless Curing Light is a device used for the polymerization of dental materials using visible light. It consists of a cordless LED curing handpiece, a battery charger and a remote handpiece holder. The plastic molded handpiece will contain a detachable rechargeable battery pack, an LED light "engine". A printed circuit board with a digital circuit will be utilized to control four different curing modes. Each mode specifies LED timing and audible beep timing. A segmented display will depict the curing modes. A separate pushbutton will activate the light. The molded plastic battery charger will have a single well for charging the battery pack, and Indictor lights to indicate battery charge status.

## Intended Use of the Device:

The intended use of the Power I.E.D is for the polymerization of visible light cured materials.

Substantial Equivalence:

Power LED is substantial equivalence to other legally marketed devices in the United States. As Power LED functions in a manner similar to and is intended for the same use as the Elipar Freelight designed by ESPE AG

> 1460 NW 107 Ave Suite G . Miami, Florida6 33140 TEL [phone] · FAX [phone] · USA

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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 is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract image of an eagle.

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

FEB 27 2004

Mr. George Echeverri Export Sales Director Dental Products of USA, Incorporated 1460 NW 107 Avenue, Suite G Miami, Florida 33172

Re: K033697

Trade/Device Name: Power LED Regulation Number: 21 CFR 872.6070 Regulation Name: Ultraviolet Activator for Polymerization Regulatory Class: II Product Code: EBZ Dated: February 13, 2004 Received: February 17, 2004

Dear Mr. Echeverri:

We have reviewed your Section 510(k) premarket notification of intent to market the indication We have reviewed your Section 510(K) premained is substantially equivalent (for the indications for referenced above and have decemblic the devices marketed in interstate on merce use stated in the encrosure) to icgain manufacture proadinents, or to devices that proof to May 28, 1970, the chacinem unto of the Federal Food, Drug, and Cosmetic
have been reclassified in accordance with the provisions of the Provincities (PMA). You may have been reclassified in accordance with the provisions on application (PMA). You may.
Act (Act) that do not require approval of a premarket approval application (PMA). The Act (Act) that do flor require approval or a premal controls provisions of the Act. The general therefore, market the device, subject to the general sense and registration, listing of devices, good controls provisions of the necessariat 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 (Sec above) into Elais) experience (1) in the claim (1) in thics can be may be subject to Such additions. Title 21, Parts 800 to 898. In addition, FDA may publish found in the Sourcements concerning your device in the Federal Register.

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Page 2 -- Mr. George Echeverri

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 of that FDA has made a delemination that your ac-treal agencies. You must comply with any Federal statures and regulations administered by outs research agently of CFR Part 807);
all the Act's requirements, including, but not limited to seations and listing (2 all the Act s requirements, including, but not inner in as set forth in the quality
labeling (21 CFR Part 801); good manufacturer in the olostrania product radiation labeling (21 CFR Part 801), good manazona.net Franplicable, the electronic product radiation
systems (QS) regulation (21 CFR Part 820); and if applicable, 1050 systems (QS) regulation (21-531-542 of the Act); 21 CFR 1000-1050.

This letter will allow you to begin marketing your device as described in your Section 510(k)
In a legal This letter will allow you to begin marketing your avince of your device of your device to a legally
premarket notification. The FDA finding of substantial equipalised the s premarket notification. The FDA midnig of substantal equive 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 auvice for your de rice on on and a many of concestions on the promotion
contact the Office of Compliance at [phone]. Additions of (201) 594-463 contact the Office of Compliance at [phone] - 1910-1910 (1911) 594-4639. Also, 1910-199 and advertising of your device, prease corrence to premarket to premarket notification writing writing writing writing writing writing writing writing writing and please note the regulation entitical "Misonation on your responsibilities under the Act may Part 807.97) you the Division of Small Manufacturers, International and Consumer Assistance at its
be obtained from the Division of Small Manufacturers, International and Con be obtained from the D 638-2041 or [phone] or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html

Sincerely yours,

Oufs

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

510(k) Number (if known): K033697

Device Name: Power LED

Indications for Use:

Intended Use for Power LED:

The intended use of Power LED is to act as a polymerization source using visible light to cure composite resins.

Prescription Use × (21 CFR Part 801 Subpart D) AND/OR

Over-The-Counter Use (21 CFR Part 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 Pumps

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

510(k) Number: k232697

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