(146 days)
The Chiropro L system is intended for use in dental surgery, endodontics, and implantology. The main unit is designed to be used with a specific dental micromotor that drives dental handpieces fitted with appropriate tools to cut hard and soft tissues in the mouth and to screw dental implants.
The Chiropro L system consists of a software-based drive unit that controls the speed of a dental micromotor. The Chiropro L system offers three different functional modes with operating parameters specific to a particular application (Implantology, Endodontics, and Dental Surgery). The Chiropro L system is equipped with an integrated peristaltic pump for use with external irrigation tubing allowing irrigation of the working area. The device is operated via the command buttons on the tabletop console or through a foot control. For implantology purposes, the Chiropro L system is intended to be used with a contra-angle handpiece with a 20:1 gearing ratio and a rotational speed between 5 rpm to 2000 rpm (designed to operate burs according to ISO1797-1, type 2). Two versions of the handpiece are available, with and without optical fibers conducting the light emitted by the motor to the surgical field.
The provided text is a 510(k) summary for the Bien-Air Dental SA Chiropro L system. This document is related to a medical device that controls dental handpieces, and it describes the device's technical characteristics and how it compares to predicate devices to demonstrate substantial equivalence for regulatory approval. It does not contain information about acceptance criteria or a study proving that a device meets those criteria in the context of diagnostic accuracy, which is typically found in AI/ML device submissions.
Therefore, I cannot extract the requested information as it is not present in the provided text. The document focuses on regulatory approval based on substantial equivalence to existing devices, electrical safety, and electromagnetic compatibility testing, rather than performance criteria that would typically be associated with diagnostic or AI-driven medical devices.
The text does not include information about:
- A table of acceptance criteria and reported device performance (in terms of diagnostic accuracy or similar metrics).
- Sample size, data provenance, number of experts, adjudication methods, MRMC studies, standalone performance, or ground truth types, as these are generally relevant for evaluating the performance of diagnostic or AI-based devices, which this submission is not.
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DEC 1 5 2009
510(k) Summary for the Bien-Air Dental SA Chiropro L system
1. SPONSOR
Bien-Air Dental, SA Langasse 60 CH - 2504 Bienne Switzerland
Contact Person: Helena Lacalle-Baumann Telephone: +41-32-344-64-64
Date Prepared: July 20, 2009
2. DEVICE NAME
Proprietary Name: Chiropro L system Common/Usual Name: Controller Classification Name: Controller, foot, handpiece and cord (Product Code EBW) under 21CFR 872.4200, dental handpiece and accessories
3. PREDICATE DEVICES
- · implantMED SI-915/923, W & H Dentalwerk, K052741
- · TI-Max-SG20L, NSK Nakanishi Inc., K970953
- · WS-75 E/KM (W & H Dentalwerk Buermoos GmbH, K011061)
4. INTENDED USE
The Chiropro L system is intended for use in dental surgery, endodontics, and implantology. The main unit is designed to operate a specific dental micromotor that drives dental handpieces fitted with appropriate tools to cut hard and soft tissues in the mouth and to screw dental implants.
5. DEVICE DESCRIPTION
The Chiropro L system consists of a software-based drive unit that controls the speed of a dental micromotor. The Chiropro L system offers three different functional modes with operating parameters specific to a particular application (Implantology,
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Endodontics, and Dental Surgery).
The Chiropro L system is equipped with an integrated peristaltic pump for use with external irrigation tubing allowing irrigation of the working area. The device is operated via the command buttons on the tabletop console or through a foot control.
For implantology purposes, the Chiropro L system is intended to be used with a contra-angle handpiece with a 20:1 gearing ratio and a rotational speed between 5 rpm to 2000 rpm (designed to operate burs according to ISO1797-1, type 2). Two versions of the handpiece are available, with and without optical fibers conducting the light emitted by the motor to the surgical field.
6. TECHNOLOGICAL CHARACTERISTICS AND SUBSTANTIAL EQUIVALENCE
The proposed Chiropro L system is identical in intended use, overall design, and function to the implantMED SI-915/923. Both the proposed and predicate devices are drive units consisting of a control unit with an integral irrigation pump and tubing, micromotor, and connecting cable. In addition, the handpieces supplied with the Chiropro L system are similar in overall design and functional characteristics to the predicate handpieces, the Ti-Max-SG20L and WS-75 E/KM.
Testing provided in this premarket notification includes electrical safety and electromagnetic compatibility testing. Test results demonstrate that the Chiropro L system can be used safely and effectively as a drive unit for dental handpieces intended for use in dental surgery, endodontics, and implantology.
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Image /page/2/Picture/1 description: The image is a seal for the Department of Health & Human Services - USA. The seal is circular and contains the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the seal is an abstract image of an eagle.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room W-O66-0609 Silver Spring, MD 20993-0002
Bien-Air Dental, SA C/O Ms. Cynthia J. Nolte Senior Regulatory Consultant Medical Device Consultants, Incorporated 49 Plain Street North Attleboro, Massachusetts 02760
DEC 1 5 2009
Re: K092214
Trade/Device Name: Chiropro L System Regulation Number: 872.4200 Regulation Name: Dental Handpiece and Accessories Regulatory Class: I Product Code: EBW Dated: December 8, 2009 Received: December 10, 2009
Dear Ms. Nolte:
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.
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 Ms. Nolte
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,
Jh far
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
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Indications for Use
510(k) Number (if known):
Device Name: Chiropro L system
Indications for Use:
The Chiropro L system is intended for use in dental surgery, endodontics, and implantology. The main unit is designed to be used with a specific dental micromotor that drives dental handpieces fitted with appropriate tools to cut hard and soft tissues in the mouth and to screw dental implants.
Prescription
Prescription Use X (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
RSber DOS for Dr. K. Mulky (Acting)
Division of Anesthesiology. General Hospital Intection Control, Dental Davices
KO92214 510(k) Number:
§ 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.