(31 days)
Not Found.
No
The summary describes a standard ultrasonic scaler and contains no mention of AI, ML, or related concepts.
Yes
The device is described as being used for "dental cleanings and periodontal therapy," which are therapeutic applications. Additionally, the predicate device is an "Ultrasonic Scaler," further indicating a therapeutic purpose.
No
The device is described as an ultrasonic scaler used for dental cleanings and periodontal therapy to remove calculus deposits, not to diagnose a condition.
No
The device is described as an "Ultrasonic Scaler" which is a hardware device used in dental procedures. The description of its function ("application of an ultrasonic vibrating scaler tip to the teeth") further confirms it is a physical instrument, not software.
Based on the provided information, the PowerMAX Ultrasonic Scaler is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to remove calculus deposits from teeth during dental cleanings and periodontal therapy. This is a direct treatment/procedure performed on the patient's teeth, not a test performed on a sample taken from the body to diagnose a condition.
- Device Description: While the description is "Not Found," the intended use clearly indicates a physical action on the teeth.
- No mention of samples or testing: There is no mention of analyzing biological samples (blood, urine, tissue, etc.) which is a core characteristic of IVDs.
- Anatomical Site: The anatomical site is "teeth," which are part of the patient's body, not a sample taken from the body.
IVDs are devices used to examine specimens derived from the human body to provide information for the diagnosis, prevention, monitoring, treatment, or alleviation of disease. The PowerMAX Ultrasonic Scaler does not fit this description. It is a therapeutic/procedural device used directly on the patient.
N/A
Intended Use / 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.
Product codes
ELC
Device Description
Not Found.
Mentions image processing
Not Found.
Mentions AI, DNN, or ML
Not Found.
Input Imaging Modality
Not Found.
Anatomical Site
teeth
Indicated Patient Age Range
Not Found.
Intended User / Care Setting
dental cleanings and periodontal therapy
Description of the training set, sample size, data source, and annotation protocol
Not Found.
Description of the test set, sample size, data source, and annotation protocol
Not Found.
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Not Found.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found.
Predicate Device(s)
Reference Device(s)
Not Found.
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found.
§ 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.
0
Public Health Service
Image /page/0/Picture/2 description: The image shows the logo for the Department of Health and Human Services - USA. The logo features a stylized eagle with three lines forming the wings and body. The text "DEPARTMENT OF HEALTH AND HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle.
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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Image /page/2/Picture/0 description: The image shows a logo for TPC Advanced Technology. The letters "TPC" are in large, bold, black font. Below the letters, the words "ADVANCED TECHNOLOGY" are in a smaller font. The logo is inside of a black rectangle.
| 510(k) Number: | K983029 K051547 |
|---|---|
| Device Name: | PowerMAX Ultrasonic Scaler -new name |
| Power 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: