(21 days)
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Not Found
No
The summary describes a cordless prophylaxis handpiece and foot pedal, with no mention of AI, ML, image processing, or data analysis that would suggest the use of such technologies.
No
The device is used to clean and polish teeth, which is a prophylactic measure, not a therapeutic treatment for a disease or condition.
No
The device is described as a "prophylaxis handpiece" used to "clean and polish teeth." This is a treatment or maintenance function, not a diagnostic one. There is no mention of identifying, analyzing, or evaluating the health or condition of teeth or any other part of the body.
No
The device description explicitly mentions a "cordless prophylaxis handpiece" and a "wireless foot pedal," which are hardware components.
Based on the provided information, the Zen Cordless Prophy System is not an IVD (In Vitro Diagnostic) device.
Here's why:
- Intended Use: The intended use is to "clean and polish teeth." This is a procedure performed directly on the patient's body (in vivo), not on samples taken from the body (in vitro).
- Device Description: The description reinforces the intended use of cleaning and polishing teeth.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples, detecting substances in samples, or providing diagnostic information based on in vitro testing.
IVD devices are used to examine specimens derived from the human body, such as blood, urine, or tissue, to provide information for diagnosis, monitoring, or screening. The Zen Cordless Prophy System does not fit this description.
N/A
Intended Use / Indications for Use
The Zen Cordless Prophy System is a high-performance cordless prophylaxis handpiece with a wireless foot pedal for use with Zen's disposable prophylaxis angles to clean and polish teeth.
Product codes
EKX
Device Description
The Zen Cordless Prophy System is a high-performance cordless prophylaxis handpiece with a wireless foot pedal for use with Zen's disposable prophylaxis angles to clean and polish teeth.
Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
teeth
Indicated Patient Age Range
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Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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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)
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Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 872.4200 Dental handpiece and accessories.
(a)
Identification. A dental handpiece and accessories is an AC-powered, water-powered, air-powered, or belt-driven, hand-held device that may include a foot controller for regulation of speed and direction of rotation or a contra-angle attachment for difficult to reach areas intended to prepare dental cavities for restorations, such as fillings, and for cleaning teeth.(b)
Classification. Class I.
0
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized caduceus symbol, which is a staff with two snakes entwined around it. To the left of the caduceus, the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
Discuss Dental, LLC C/O Mr. Jeff D. Rongero Responsible Third Party Official . Underwriters Laboratories, Incorporated 12 Laboratory Drive Research Triangle, North Carolina 27709
JUN 3 0 2010
Re: K101612
Trade/Device Name: Zen Cordless Prophy System Regulation Number: 21 CFR 872.4200 Regulation Name: Dental Handpiece and Accessories Regulatory Class: I Product Code: EKX Dated: June 24, 2010 Received: June 25, 2010
Dear Mr. Rongero:
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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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. Rongero
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); medical device reporting (reporting of medical device-related adverse.events) (21 CFR 803); 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.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to
http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
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) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.
Sincerely yours.
hn for
Anthony D. Watson, B.S., M.S., M.B.A. 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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E. Indications for Use Statement
510(k) Number: .
Device Name: Zen Cordless Prophy System
Intended Use
.
The Zen Cordless Prophy System is a high-performance cordless prophylaxis handpiece with a wireless foot pedal for use with Zen's disposable prophylaxis angles to clean and polish teeth.
Prescription Use x (21 CFR Part 801 Subpart D) And/Or
Over the Counter Use (21 CFR Part 801 Subpart C)
166
(PLEASE DO NOT WRITE BELOW THIS LINE; CONTINUE ON ANOTHER PAGE IF NEEDED) .
Concurrence of CDRH, Office of In Vitro Diagnostic Device Evaluation and Safety (OIVD)
Lei Muly for MSE
(Division Sign-Off)
Division of Anesthesiology, General Hospital Infection Control, Dental Devices
510(k) Number: K101612
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