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Not Found
No
The summary describes a standard dental system providing basic utilities (air, water, vacuum, electricity) and a user interface for controlling dental devices. There is no mention of AI, ML, image processing, or data analysis that would indicate the use of such technologies.
No
The device provides a user interface to control other dental devices and delivers air, water, vacuum, and electricity for common dental procedures. It does not directly provide therapy itself but rather facilitates the use of therapeutic tools.
No
The provided text describes the device as a system that delivers air, water, vacuum, and electricity to control dental devices for "common and normal patient treatment procedures." It doesn't mention any function related to identifying, analyzing, or diagnosing medical conditions.
No
The device description explicitly states that the system "delivers air, water, vacuum and electricity" and controls "dental charted dental devices," indicating it includes hardware components beyond just software.
Based on the provided information, the R7 Dental System is not an IVD (In Vitro Diagnostic) device.
Here's why:
- Intended Use/Indications for Use: The description clearly states the system is for "general dental applications" and provides a user interface to control dental devices for "common and normal patient treatment procedures." This involves direct interaction with the patient and performing procedures within the dental operatory.
- Device Description: The description reinforces this by detailing the delivery of air, water, vacuum, and electricity to power and control dental instruments.
- Lack of IVD Characteristics: IVD devices are used to examine specimens derived from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening. The R7 Dental System does not perform any such analysis of biological specimens.
The R7 Dental System is a piece of dental equipment used to facilitate dental procedures performed directly on a patient.
N/A
Intended Use / Indications for Use
The R7 Dental System and accessories are in general dental applications by providing the dental practitioner a user interface to control operation of the dental charted dental devices. The system delivers air, water, vacuum and electricity to allow the dental practitioner an intuitive control common and normal patient treatment procedures, including use of an ultrasonic scaler, performed in the dental operatory.
Product codes
ELC, EIA
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
dental practitioner / dental operatory
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)
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Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
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Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
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Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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§ 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.
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Image /page/0/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo features a stylized depiction of a human figure embracing a globe, symbolizing the department's mission to protect the health of all Americans and provide essential human services. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the emblem.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
October 8, 2013
CEFLA s.c. C/O Mr. Claude Berthoin President Thema USA/Denterprise International. Incorporated 110 E. Granada Boulevard, Suite 209 ORMOND BEACH FL 32176
Re: K130834
Trade/Device Name: R7 Regulation Number: 21 CFR 872.4850 Regulation Name: Ultrasonic Scaler Regulatory Class: II Product Code: ELC, EIA Dated: September 3, 2013 Received: September 9, 2013
Dear Mr. Berthoin:
We have reviewed vour 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. Berthoin
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 contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. 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.
Mary S-Runner -S
Kwame Ulmer, M.S. Acting Division Director Division of Anesthesiology, General Hospital, Respiratory, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
Form Approved: OMB No. 0910-0120 Expiration Date: December 31, 2013 See PRA Statement on last page.
510(k) Number (if known) K130834
R7 Dental System
Indications for Use (Describe)
Device Name
The R7 Dental System and accessories are in general dental applications by providing the dental practitioner a user interface to control operation of the dental charted dental devices. The system delivers air, water, vacuum and electricity to allow the dental practitioner an intuitive control common and normal patient treatment procedures, including use of an ultrasonic scaler, performed in the dental operatory.
Type of Use (Select one or both, as applicable)
Prescription Use (Part 21 CFR 801 Subpart D)
] Over-The-Counter Use (21 CFR 801 Subpart C)
Please do not write below this line - continue on a separate page if needed.
CONTRACTOR PORTER OF THE FOR FDALUSE ONLY FOR FOR MILLER SELLER SELLER SELLERS FOR FOR
Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)
Image /page/2/Picture/14 description: The image shows the name "Andrew I. Steen" in bold, black font. Below the name, the date "2013.10.08" and time "14:00" are printed in a similar font. There is also a stamp on the right side of the image.