MICROLUX DL

K041614 · Addent, Inc. · EAZ · Apr 4, 2005 · Dental

Device Facts

• Record ID: K041614
• Device Name: MICROLUX DL
• Applicant: Addent, Inc.
• Product Code: EAZ · Dental
• Decision Date: Apr 4, 2005
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.4630
• Device Class: Class 1

Intended Use

This device is used as an aid to improve the visualization of oral lesions. It is designed to be used by a dentist or health care provider, in combination with a traditional examination by incandescent light.

Device Story

Microlux/DL is an intraoral examination light; battery-powered; utilizes blue-white LED (6500°K) and rigid diffused fiber optic light guide. Used by dentists/healthcare providers in clinical settings. Procedure involves patient rinsing with 1% acetic acid; clinician illuminates oral mucosa with device to enhance lesion visualization. Provides diffused blue-white light to assist in identifying oral lesions; intended as adjunct to standard incandescent light examination. Benefits include improved contrast/visibility of mucosal lesions.

Clinical Evidence

No clinical data provided; substantial equivalence based on technological comparison to predicate devices.

Technological Characteristics

Battery-powered intraoral light; blue-white LED light source (6500°K, chromaticity X=0.31, Y=0.32); rigid diffused fiber optic light guide. Non-tissue contacting. No software or complex algorithms.

Indications for Use

Indicated for use by dentists or healthcare providers as an aid to improve visualization of oral lesions in conjunction with traditional incandescent light examination.

Regulatory Classification

Identification

A dental operating light, including the surgical headlight, is an AC-powered device intended to illuminate oral structures and operating areas.

Predicate Devices

• Speculite/OraLite (K012070, K003995)
• Visilite (K012070, K003995)

Submission Summary (Full Text)

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APR - 4 2005

K041614

# REVISED 510(k) SUMMARY

| Submitters Name: | Joshua Friedman, D.D.S | Date of Submission: March 28, 2005 |
|----------------------|--------------------------------------------------------|------------------------------------|
| Address: | AdDent, Inc.<br>43 Miry Brook Rd.<br>Danbury, CT 06810 | Contact Person: Joshua Friedman |
| Phone: | [phone] | E-mail: [e-mail] |
| Fax: | [phone] | |
| Device Name: | Microlux/DL | |
| Common Name: | Intra Oral Examination Light | |
| Classification Name: | Light, Fiber Optic, Dental | |

Marketed Device of Equivalence: Visilite

## Description of Device:

The Microlux/DL is used to enhance dental examination of lesions of the oral mucosa. The device consists of a battery powered light source that uses a blue-white LED, a rigid diffused fiber optic light guide. It is used in conjunction with a non-toxic dilute (1%) acetic acid rinse for the viewing of oral lesions. The fiber optic illuminator itself is non-tissue contacting, and is classified as a 510(k) Exempt FDA Device.

Intended Use: The Microlux/DL is used as an aid to improve visualization of oral lesions.

### Characteristics of Microlux/DL Compared to Predicate Device:

The Microlux DL compares favorably and is substantially equivalent to another legally marketed device. The Microlux DL functions in a manner similar to and is used for the same purpose as the Speculite/OraLite manufactured by Trylon Corp. It is also sold under the name Visilite™ by Zila, Inc. The 510K number of the predicate device is K012070 and K003995.

The OraLite uses a chemical luminescent light source that produces a diffused blue-white light. The Microlux DL uses a blue-white LED and a diffused fiber optic light guide to provide a diffused blue-white light. The LED in the Microlux/DL has a color temperature of 6500°K and nominal chromaticity coordinates of X= .31 and Y =.32.

The OraLite uses a 1% acetic acid mouth rinse prior to examination. The Microlux DL uses a 1% acetic acid mouth rinse prior to examination.

Essentially, the only difference between the Microlux DL and the predicate device is that the Microlux DL uses a Blue-White LED as a light source and the Visilite uses a Blue-White chemical luminescent light source. The associated 1% acetic rinse and diagnostic procedure are identical.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" around the perimeter. Inside the circle is a stylized image of an eagle with three horizontal lines above it, representing the department's mission to protect the health of all Americans and provide essential human services.

#### Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

APR - 4 2005

Joshua Friedman, DDS President AdDent, Incorporated 43 Miry Brook Road Danbury, Connecticut 06810

Re: K041614

Trade/Device Name: Microlux/DL Regulation Number: 21 CFR 872.4630 Regulation Name: Dental Operating Light Regulatory Class: I Product Code: EAZ Dated: February 3, 2005 Received: February 7, 2005

Dear Dr. Frieman:

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 - Dr. Frieman

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.

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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K041614

# INDICATIONS FOR USE

510(k) Number (if known): K041614

Device Name: Microlux/DL

Indications for Use:

This device is used as an aid to improve the visualization of oral lesions. It is designed to be used by a dentist or health care provider, in combination with a traditional examination by incandescent light.

Prescription Use
(Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use (21 CFR 801 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE) (Division Sign-Oif) Olvision of Anesthesiology, General Hospital, Page 1 of 1 Infection Control, Dental Devices 510(k) Number