TOESCO AQUA BLUE LED LIGHT CURING DEVICE

K021374 · Toei Electric Co., Ltd. · EBZ · May 30, 2002 · Dental

Device Facts

• Record ID: K021374
• Device Name: TOESCO AQUA BLUE LED LIGHT CURING DEVICE
• Applicant: Toei Electric Co., Ltd.
• Product Code: EBZ · Dental
• Decision Date: May 30, 2002
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.6070
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Toesco Aqua Blue LED Light Curing Device is intended to provide visible light irradiation for the curing of dental VLC resin products.

Device Story

Toesco Aqua Blue LED Light Curing Device is a gun-handle shaped dental curing light. It uses a light-emitting diode (LED) to emit blue light (450-480 nm, peak 470 nm) to polymerize dental resins and sealants. The device is operated by dental professionals in a clinical setting. It features two full-power modes and a 2-step curing mode, with three pre-set and seven user-defined programs. Power is supplied by a 7.4V Lithium Ion battery. The clinician directs the light through a light-guiding tip onto the dental material to initiate curing. This process facilitates the hardening of restorative materials, benefiting the patient by ensuring proper structural integrity of dental fillings or sealants.

Clinical Evidence

No clinical data. Substantial equivalence is supported by non-clinical bench testing, including electrical safety (IEC 60601-1-1, IEC 60601-1-2), battery and charger testing, environmental testing, and reliability testing.

Technological Characteristics

Gun-handle form factor; LED light source (450-480 nm, peak 470 nm); 7.4V Lithium Ion battery power source; 23VA power consumption. Complies with IEC 60601-1-1 and IEC 60601-1-2 standards. Features multiple curing modes (full power, 2-step) and programmable settings.

Indications for Use

Indicated for the curing of dental visible light-cured (VLC) resin products 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

• CoolBlu Curing Light, Dental System.com, Inc. (K002925)

Submission Summary (Full Text)

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MAY 3 0 2002

KQ21374

EXHIBIT #1

# 510(K) SUMMARY

This summary of 5l0(k) safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR §807.92.

The assigned 5l0(k) number is:

#### 1. Submitter's Identification:

Toei Electric Co., Ltd. 771, Shimosakunobe, Takatsu-ku Kawasaki-shi, Kanagawa-Ken 213-0033 Japan

Date Summary Prepared: April 29, 2002

Mr. Kazuhiro Tachibana Contact Person: Overseas Sales Marketing Manager

#### 3. Name of the Device:

Toesco Aqua Blue LED Light Curing Device

#### 3. Predicate Device Information:

K# 002925, CoolBlu Curing Light, Dental System.com, Inc., Heathrow, Florida

#### 4. Device Description:

The Toesco Aqua Blue Led Light Curing Device is a gun-handle shaped dental curing light that is intended to polymerize dental materials such as resins and sealants by transmitting light through a light guiding tip. The source of blue light is a light-emitting diode. The device has two optional curing modes: two full power modes and a 2-step curing mode. It incorporates three pre-set programs and seven user programs. The power source is a 7.4 V Lithium Ion Battery. Wavelength is 450 nm - 480 nm, with wavelength peaking at 470nm.

#### Intended Use: 5.

The Toesco Aqua Blue LED Light Curing Device is intended to provide visible light irradiation for the curing of dental VLC resin products.

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#### Comparison to Predicate Devices: દ.

Both the subject and predicate devices use an LED light source, but of differing light intensities (subject device is 330mW/cm² and predicate device is 320mW/cm², and a battery power source (subject device uses lithium ion battery, 7 .4V and predicate device uses Nickel Cadmium battery - power consumption for subject device is 23VA, and predicate device is 18VA). The respective configurations of the two devices show no major differences, and, are substantially equivalent in intended use and design.

### Discussion of Non-Clinical Tests Performed for Determination of 7. Substantial Equivalence are as follows:

IEC 60601-1-1, IEC 60601-1-2, Battery and Charger Testing, Environmental Testing, Reliability Testing.

#### Discussion of Clinical Tests Performed: 8.

Not Applicable

#### 9. Conclusions:

The Toesco Aqua Blue LED Light Curing Device has the same intended use and similar characteristics as the CoolBlu Curing Light Device. Moreover, non-clinical testing (bench testing) demonstrates that any differences in their technological characteristics do not raise any new questions of safety or effectiveness. Thus, the Toesco Aqua Blue LED Light Curing Device is substantially equivalent to the predicate device.

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## DEPARTMENT OF HEALTH & HUMAN SERVICES

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Toei Electric Company Limited C/O Susan D. Goldstein-Falk MDI Consultants, Incorporated 55 Northern Boulevard, Suite 200 Great Neck, New York 11021

MAY 3 0 2002

Re: K021374

Trade/Device Name: Toesco Aqua Blue LED Light Curing Device Regulation Number: 872.6070 Regulation Name: Ultraviolet Activator for Polymerization Regulatory Class: II Product Code: EBZ Dated: April 29, 2002 Received: May 01, 2002

Dear Ms. Goldstein-Falk :

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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Please be advised that FDA's issuance of a substantial equivalence determination does not mean I tease of actived that I Drimination that your device complies with other requirements of the Act that I DA has made a acterimentations administered by other Federal agencies. You must or any I with all the Act's requirements, including, but not limited to: registration and listing (21 Comply with an the Act 3 requirements) and manufacturing practice requirements as set CI K Part 6077; Mooning (21 CFR Part 820); and if applicable, the electronic forth in also qualis) 35 receives (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 lotter will and in yourse FDA finding of substantial equivalence of your device to a legally premated noticated.com " 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 11 you desire specific art 809.10 for in vitro diagnostic devices), please contact the Office of additionally 21 OFF Carol (3. Additionally, for questions on the promotion and advertising of Compinatee at (301) 59 + t 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 Oinor gonetar mionination turers, 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,

Paltrow Cucinotta

Timothy A. Ulatowski Director Division of Dental, Infection Control, and General Hospital Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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: Exhibit B

of Page

K021374

510(k) Number (if known):

Device Name: Toesco Aqua Blue LED Light Curing Device

### Indications For Use:

The Toesco Aqua Blue LED Light Curing Device is intended to provide visible light irradiation for the curing of dental VLC resin products.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use (Per 21 CFR 801.109)

OR

Over-The-Counter Use (Optional Format 1-2-96)

Susa Prome

(Division Sign-Off) (Division of Dental, Infection Control, and General Hospital Deyicqosing 1 510(k) Number -