(31 days)
The PowerMAX Ultrasonic Scaler is intended for use during dental cleanings and periodontal therapy to remove calculus deposits form teeth by application of an ultrasonic vibrating scaler tip to the teeth.
Not Found
This is a 510(k) premarket notification for a dental ultrasonic scaler, not an AI/ML device, therefore the requested information regarding acceptance criteria, study data, sample sizes, and expert adjudication for AI/ML performance is not applicable. The document confirms that the device, PowerMAX Ultrasonic Scaler, is substantially equivalent to legally marketed predicate devices for dental cleanings and periodontal therapy.
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Public Health Service
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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUL 1 4 2005
TPC Advanced Technology, Incorporated c/o Mr. Scott Beckley 17588 E. Rowland St., Suite #286 City of Industry, California 91748
Re: K051547
Trade/Device Name: PowerMax Ultrasonic Scaler Regulation Number: 21 CFR 872.4850 Regulation Name: Ultrasonic Scaler Regulatory Class: II Product Code: ELC Dated: June 02, 2005 Received: July 14, 2005
Dear Mr. Beckley:
We have reviewed your Section 510(k) premarket notification of intent to market the device we nave reviewed your booteermined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate for use stated in the encreativent date of the Medical Device Amendments, or to Conninered processified in accordance with the provisions of the Federal Food. Drug, devices that have been recure approval of a premarket approval application (PMA). allo Cosmetic Ac. (110) that do not request to the general controls provisions of the Act. The I ou may, dicrororo, mainer of the Act include requirements for annual registration, listing of general voltario profitaturing 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 If your device is classified (600 woor of ols. Existing major regulations affecting your device can may be subject to subli additions, Title 21, Parts 800 to 898. In addition, FDA may ou louically the Overnments concerning your device in the Federal Register.
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Page 2 - Mr. Beckley
Please be advised that FDA's issuance of a substantial equivalence determination does not mean i lease oe acternination that your device complies with other requirements of the Act that I Dri has made a cond regulations administered by other Federal agencies. You must or any I could butther and sequirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set CI K rat 607); idoomig (21 CFR Part 820); and if applicable, the electronic forth in the qualis) 35,000 provisions (Sections 531-542 of the Act); 21 CFR 1000-1050. product radiation come of provesin marketing your device as described in your Section 510(k) I mis letter will and w you've ough finding of substantial equivalence of your device to a legally prematics notification. Theesults 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 If you debire 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 other general mionnation 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,
Sybilie L. Michie Dm-D.
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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| 510(k) Number: | K983029 K051547 |
|---|---|
| Device Name: | PowerMAX Ultrasonic Scaler -new namePower Plus Ultrasonic Scaler- former name |
| Indications for Use: | The PowerMAX Ultrasonic Scaler is intended for use during dental cleanings and periodontal therapy to remove calculus deposits form teeth by application of an ultrasonic vibrating scaler tip to the teeth. |
| Prescription Use | |
| and/or | |
| 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 S. Betz DDS for Dr. Susan Runner
(Division Sign eneral Hospital, (Division of Anesthesiology Division Control, Der
510(k) Number:
§ 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.