(94 days)
Not Found
Not Found
No
The summary explicitly states "Mentions AI, DNN, or ML: Not Found" and provides no other information suggesting the use of AI/ML.
No
Explanation: The device is intended for dental applications such as scaling, periodontics, prosthesis, and endodontics, which are procedures rather than therapeutic interventions for specific diseases or conditions.
No
Explanation: The device is described as an ultrasonic generator used for various dental applications like scaling, periodontics, prosthesis, and endodontics. These are treatment procedures and do not involve diagnosing a condition.
No
The device description explicitly states it is a "Dental Ultrasonic Generator," which is a hardware device. There is no mention of software being the primary or sole component.
Based on the provided information, the ProUltra Piezo Ultrasonic is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states it's for dental applications like scaling, periodontics, prosthesis, and endodontics. These are procedures performed directly on the patient's teeth and surrounding tissues.
- Device Description: It's described as a "Dental Ultrasonic Generator," which is a piece of equipment used in dental procedures.
- Lack of IVD Characteristics: The description does not mention any of the typical characteristics of an IVD, such as:
- Analyzing samples (blood, urine, tissue, etc.)
- Providing information about a patient's health status based on in vitro analysis.
- Using reagents or kits for testing.
IVDs are devices used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. The ProUltra Piezo Ultrasonic is a therapeutic and procedural device used directly in the mouth, not for analyzing samples.
N/A
Intended Use / Indications for Use
The ProUltra Piezo Ultrasonic is a Dental Ultrasonic Generator intended for use with The Frookia , lead on for, scaling, periodontics, prosthesis and endodontic Dental Applications.
Product codes
ELC
Device Description
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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
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Indicated Patient Age Range
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Intended User / Care Setting
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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
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Key Metrics
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Predicate Device(s)
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Reference Device(s)
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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
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized eagle with three horizontal lines extending from its body. The eagle is positioned to the right of the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA", which is arranged in a circular fashion around the left side of the logo.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
Satelec-Acteon Group C/O Mr. Rick Rosati Quality Manager Acteon, Incorporated . 124 Gaither Drive, Suite 140 Mount Laurel, New Jersey 08054
Re: K113430
Trade/Device Name: ProUltra Piezo Ultrasonic Regulation Number: 21 CFR 872.4850 Regulation Name: Ultrasonic Scaler Regulatory Class: II Product Code: ELC Dated: February 9, 2012 Received: February 10, 2012
Dear Mr. Rosati:
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 mendments, or to devices that have been reclassified in accordance with the provisions of Amendinents, or to act research Act (Act) that do not require approval of a premarket the rederal I ood, Drug, and Ocomonay, therefore, market the device, subject to the general approvincians of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, legallements for unnual regionations and adulteration. Please note: CDRH does not evaluate informations against institution. 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 (1 MIx), It may=00_babyon-o-ade of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements conceming your device in the Federal Register.
FEB 2 3 2012
1
Page 2- Mr. Rosati
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, BS, MS, MBA Director
Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation
Center for Devices and
Radiological Health
Enclosure
2
Section 04 – Indication for Use
Indications for Use
KI18430
510(k) Number (if known):
Device Name:
ProUltra Piezo Ultrasonic
Indications for Use:
The ProUltra Piezo Ultrasonic is a Dental Ultrasonic Generator intended for use with The Frookia , lead on for, scaling, periodontics, prosthesis and endodontic Dental Applications.
Prescription Use _____________________________________________________________________________________________________________________________________________________________ (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
(Please Do Not WRITE BELOW THIS LINE – CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Susan Penroe
(Division Sign-Off) (Division Sign-Off)
Division of Anesthealbagy, General Hospital
Division of Anesthealbagy, Canada Caujane Division Control, Dental Devices
510(k) Number: K113430