MICROLUX TRANSILLUMINATOR

K062961 · Addent, Inc. · NTK · Feb 8, 2007 · Dental

Device Facts

• Record ID: K062961
• Device Name: MICROLUX TRANSILLUMINATOR
• Applicant: Addent, Inc.
• Product Code: NTK · Dental
• Decision Date: Feb 8, 2007
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.1745
• Device Class: Class 2

Intended Use

The Microlux Transilluminator is a screening device used as an aid in visualizing caries and crown fractures. It also functions as an auxiliary light source to aid in operative procedures and preventive dentistry.

Device Story

Microlux Transilluminator is a battery-powered, handheld dental screening device. It utilizes a high-output LED light source and a detachable, autoclavable fiber-optic glass light guide (available in 2mm or 3mm tips). The device is operated by dental professionals in a clinical setting to provide transillumination for visualizing caries and crown fractures, or as an auxiliary light source during operative and preventive procedures. Disposable sleeves are available to cover the unit for infection control. The device provides visual illumination to assist the clinician in identifying dental pathologies, thereby aiding in clinical decision-making and treatment planning.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Battery-powered (three 'N' size batteries) LED light source. Fiber-optic glass light guide (2mm or 3mm tips). Autoclavable light guide; light source is wipe-disinfectable. Disposable sleeves available for cross-contamination prevention.

Indications for Use

Indicated for use during initial dental examinations to assist in the localization of crown fractures and posterior or anterior caries.

Regulatory Classification

Identification

A laser fluorescence caries detection device is a laser, a fluorescence detector housed in a dental handpiece, and a control console that performs device calibration, as well as variable tone emitting and fluorescence measurement functions. The intended use of the device is to aid in the detection of tooth decay by measuring increased laser induced fluorescence.

Special Controls

*Classification.* Class II, subject to the following special controls:(1) Sale, distribution, and use of this device are restricted to prescription use in accordance with § 801.109 of this chapter; (2) Premarket notifications must include clinical studies, or other relevant information, that demonstrates that the device aids in the detection of tooth decay by measuring increased laser induced fluorescence; and (3) The labeling must include detailed use instructions with precautions that urge users to: (i) Read and understand all directions before using the device, (ii) Store probe tips under proper conditions, (iii) Properly sterilize the emitter-detector handpick before each use, and (iv) Properly maintain and handle the instrument in the specified manner and condition.

Predicate Devices

• Welch Allyn Fiber Optic Transilluminator

Reference Devices

• Novar (transilluminator)
• Cameron (transilluminator)

Submission Summary (Full Text)

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## 510(k) SUMMARY

Submitters Name: Joshua Friedman, D.D.S

8 2007 FEB

Address: AdDent, Inc 43 Mirv Brook Rd. Danbury, CT 06810

Phone: [phone]

Fax: [phone]

Device Name: Microlux Transilluminator

Common Name: Fiber Optic Transilluminator

Classification Name: Not officially classified

Marketed Device of Equivalence: Welch Allyn Fiber Optic Transilluminator.

Description of the Device: The Microlux Transilluminator consists of a battery powered, high output L.E.D. light source, (three 'N" size batteries are included) and a fiber-optic glass light guide with either a 3mm or 2mm tip. The fiber-optic glass light guide snaps into the light source. The fiber-optic light guide is autoclaveable. The light source can be wiped with disinfectant. Disposable custom fitted sleeves are also available the cover the entire unit to prevent cross contamination.

Intended Use: The Microlux Transilluminator is a screening device used as an aid in visualizing caries and crown fractures. It also functions as an auxiliary light source to aid in operative procedures and preventive dentistry.

Characteristics of the Microlux Transilluminator Compared to Predicate Device: The Microlux Transilluminator is based on similar construction and application as the predicate devices with the exception of the light source. The Microlux uses a L.E.D.. The Novar and the Welch Allyn both use halogen lamps. The Cameron unit uses an incandescent lamp.

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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 circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES. USA" around the perimeter. In the center of the circle is a stylized symbol that resembles an abstract human figure.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

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

8 2007 FEB

Re: K062961

Trade/Device Name: Microlux Transilluminator Regulation Number: 872.1745 Regulation Name: Laser Fluorescence Caries Detection Device Regulatory Class: II Product Code: NTK Dated: January 11, 2007 Received: January 16, 2007

Dear Dr. Friedman:

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. Friedman

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 yours,

Susan Russe
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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K062961

## INDICATIONS FOR USE

510(k) Number (if known):

Device Name: Microlux Transilluminator

Indications for Use: The Microlux Transilluminator is a device used upon initial examination of the dental patient to help locate crown fractures, posterior and anterior caries.

intended Use: The Microlux Transilluminator is a screening device used to help locate caries and crown fractures. It also functions as an auxiliary light source to aid in operative procedures and preventive dentistry.

Susan Pearson

Division of Anesthesiology: General Hospital
Infection Control: Dental Services

Prescription Use *X*
(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)