SAPPHIRE O/E ORAL EXAMINATION SYSTEM

K073483 · Den-Mat Holdings, LLC · NXV · Apr 3, 2008 · Dental

Device Facts

• Record ID: K073483
• Device Name: SAPPHIRE O/E ORAL EXAMINATION SYSTEM
• Applicant: Den-Mat Holdings, LLC
• Product Code: NXV · Dental
• Decision Date: Apr 3, 2008
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.6350
• Device Class: Class 2

Intended Use

The Sapphire O/E oral examination light is intended for use by a dentist or qualified health-care provider as an adjunct to traditional oral examination by white light to enhance the visualization of oral mucosal abnormalities that may not be apparent or visible to the naked eye, such as oral cancer or pre-malignant dysphasia. Sapphire O/E oral examination light is further intended to be used by a surgeon to help identify diseased tissue around a clinically apparent lesion and thus aid in determining the appropriate margin for surgical excision.

Device Story

Sapphire O/E Oral Examination System is an ultraviolet (UV) light-based device used by dentists and surgeons. It functions as an adjunct to standard white light oral examinations. The device emits light to enhance visualization of oral mucosal abnormalities, including potential oral cancer or pre-malignant dysplasia, which may be invisible to the naked eye. Surgeons utilize the device to identify diseased tissue surrounding clinically apparent lesions, assisting in the determination of surgical excision margins. The device is operated in a clinical setting by a healthcare professional. The output is visual, allowing the clinician to observe fluorescence or tissue appearance changes under UV illumination to inform clinical decision-making regarding biopsy or surgical planning.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Ultraviolet detector; handheld light source; intended for oral mucosal visualization; Class II device; Product Code NXV.

Indications for Use

Indicated for use by dentists or qualified healthcare providers as an adjunct to white light oral exams to enhance visualization of oral mucosal abnormalities (e.g., oral cancer, pre-malignant dysplasia) and by surgeons to identify diseased tissue margins around clinically apparent lesions.

Regulatory Classification

Identification

An ultraviolet detector is a device intended to provide a source of ultraviolet light which is used to identify otherwise invisible material, such as dental plaque, present in or on teeth.

Submission Summary (Full Text)

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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three tail feathers, representing the three levels of government: federal, state, and local. The eagle is encircled by the text "DEPARTMENT OF HEALTH & HUMAN SERVICES, USA".

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Mr. Alan Matthews Quality Assurance Manager Den-Mat Holdings, LLC 2727 Skyway Drive Santa Maria, California 93455

APR - 3 2008

Re: K073483

Trade/Device Name: Sapphire™ O/E Oral Examination System Regulation Number: 872.6350 Regulation Name: Ultraviolet Detector Regulatory Class: II Product Code: NXV Dated: December 7, 2007 Received: January 10, 2008

Dear Mr. Matthews:

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 - Mr. Matthews

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.

Sina Rames
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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## SECTION 4. Den-Mat Sapphire O/E 510(k) Premarket Notification

510(k) Number (if known): pending

Sapphire™ O/E Oral Examination System Device Name:

Indications for use:

The Sapphire O/E oral examination light is intended for use by a dentist or qualified health-care provider as an adjunct to traditional oral examination by white light to enhance the visualization of oral mucosal abnormalities that may not be apparent or visible to the naked eye, such as oral cancer or pre-malignant dysphasia. Sapphire O/E oral examination light is further intended to be used by a surgeon to help identify diseased tissue around a clinically apparent lesion and thus aid in determining the appropriate margin for surgical excision.

Prescription Use _x__

and/or

OTC Use __

(Per 21 CFR 801 subpart D)

(Per 21 CFR 801 subpart C)

Susan Runne

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

510(k) Number: K073483