(90 days)
Ultrasonic applications for: All subgingival and supra gingival scaling, Periodontal therapy, and routine prophylaxis procedures
BioSonic Ultrasonic Scaler System
The provided text is a 510(k) premarket notification letter from the FDA for a device called "BioSonic Ultrasonic Scaler System". This document does not describe acceptance criteria, a study proving device performance, sample sizes, expert qualifications, or any of the other specific details requested in the prompt about a clinical study for a medical device.
The letter is an approval notification for marketing the device based on its substantial equivalence to a legally marketed predicate device, not a report on the results of a contemporary performance study.
Therefore, I cannot fulfill the request using only the provided text. The requested information is not present in this document.
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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JAN 20 1999
Mr. Harry J. Vogelstein Official Correspondent Coltene/Whaledent, Incorporated 750 Corporate Drive Mahwah, New Jersey 07430-2009
K983727 Re : BioSonic Ultrasonic Scaler System Trade Name: Regulatory Class: II Product Code: ELC October 21, 1998 Dated: Received: October 22, 1998
Dear Mr. Vogelstein:
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we 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). 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 (Premarket Approval), 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 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory In addition, FDA may publish further announcements action. concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531
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Page 2 - Mr. Vogelstein
through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or requlations.
This letter will allow you to begin marketing your device as described in your 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 requlation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4692. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the requlation entitled, "Misbranding by reference to premarket notification" (21CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its internet address
"http://www.fda.gov/cdrh/dsma/dsmamain.html".
Sincerely yours,
Timothy A. Ulatowski
A. Ulatowski Director Division of Dental, Infection Control, and General Hospital Devices Office of Device Evaluation Center for Devices and Radioloqical Health
Enclosure
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Coltène/Whaledent Inc. 510(k) Submission
510(k) Number (if krown)
: BioSonic Ultrasonic Scaler System Device Name: Indications
Indications For Use:
Ultrasonic applications for
- All subgingival and supra gingival scaling.
- and routine prophylaxis procedures
183727
- Periodontal therapy
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Hercil Sheffer
(Division Sign-Off)
Division of De Infection Control,
and General Hospital Devices
510(k) Number K983727
Prescription Use
(Per 21 CFR 801.109)
OR
Over-The-Counter Use
(Optional Formal 1-2-96)
§ 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.