(114 days)
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.
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The provided text primarily focuses on the FDA's regulatory decision regarding the Sapphire™ O/E Oral Examination System and does not contain the detailed information required to describe the acceptance criteria and the study that proves the device meets those criteria.
The document is a 510(k) premarket notification approval letter, indicating that the device has been deemed substantially equivalent to a predicate device. It defines the device's indications for use but does not delve into the specific performance studies, acceptance criteria, or statistical details of those studies.
Therefore, I cannot provide the requested information based on the given input. The document is a regulatory approval notice, not a study report.
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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 (240) 276-0115. 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 (800) 638-2041 or (301) 443-6597 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
§ 872.6350 Ultraviolet detector.
(a)
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.(b)
Classification. Class II.