(12 days)
Protégé Ultrasonic Inserts, both 25KHz and 30KHz models, are intended to be used in the handpieces of any magnetostrictive ultrasonic scaler for dental cleaning and the removal of tenacious calculus deposits by application of an ultrasonic vibrating tip to the teeth.
Protégé Ultrasonic Insert Devices
The provided document is a 510(k) premarket notification letter from the FDA for dental ultrasonic inserts. This type of document declares substantial equivalence to a predicate device and does not contain the detailed study information regarding acceptance criteria, sample sizes, expert qualifications, or ground truth that would typically be found in a clinical study report or a more comprehensive technical document.
Therefore, I cannot extract the requested information from this document. The document primarily focuses on regulatory approval and does not provide specifics on device performance beyond stating its intended use.
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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUL 1 3 2005
Discus Dental Incorporated C/O Mr. Alfredo J. Quattrone, Ph.D., DABT Responsible Third Party Official California Department of Health Services Food & Drug Branch P.O. Box 997 413 Sacramento, California 95899-7413
Re: K051776
Trade/Device Name: Protégé Ultrasonic Insert Devices Regulation Number: 21 CFR 872.4850 Regulation Name: Ultrasonic Scaler Regulatory Class: II Product Code: ELC Dated: June 22, 2005 Received: July 1, 2005
Dear Dr. Quattrone:
We have reviewed your Section 510(k) premarket notification of intent to rnarket 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. Quattrone
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,
Quen Sulion for
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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Discus Dental Protégé Ultrasound Inserts
510(k) Submission (rev'd)
Indications for Use Statement V.
510(k) Number: K051776
Device Name: Protégé Ultrasonic Insert Devices
Intended Use
Protégé Ultrasonic Inserts, both 25KHz and 30KHz models, are intended to be used in the handpieces of any magnetostrictive ultrasonic scaler for dental cleaning and the removal of tenacious calculus deposits by application of an ultrasonic vibrating tip to the teeth.
Prescription Use __ XX Per 21 CFR Section 801.109) Over-The-Counter Use _________________________________________________________________________________________________________________________________________________________
(PLEASE DO NOT WRITE BELOW THIS LINE – CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Robert J. Betz, DDS for Dr. Susan Runner
OR
sthesiology, General Hospital, Division of Ancol, Dental Devices
510(k) Number: K051776
p.07/ rev'd
§ 872.4850 Ultrasonic scaler.
(a)
Identification. An ultrasonic scaler is a device intended for use during dental cleaning and periodontal (gum) therapy to remove calculus deposits from teeth by application of an ultrasonic vibrating scaler tip to the teeth.(b)
Classification. Class II.