(106 days)
The NuTorque Programmable Electric System is used by trained dental professionals to perform general dental procedures including crown preparation, cavity preparation, crown finishing, inlay and the filling, polishing, prophylaxis and endodontic treatment.
The NuTorque Programmable Electric System is an electric handpiece system for use in performing various dental procedures including grinding and trimming. post and pin drilling, pin setting, finishing, polishing, endodontic, caries removal and prophylaxis.
The NuTorque Programmable Electric System is composed of a power supply. control unit, cable and brushless micromotor. The control unit controls the torque, speed and directional rotation of the motor. The system is programmed through the use of a color touch screen on the control unit. The motor has a rotational speed of 100- 40,000 rpm's and can be operated in a clockwise or counterclockwise direction. The system also provides variable light intensity to the handpiece.
The provided text is a 510(k) summary for the NuTorque Programmable Electric System, a dental handpiece system. It describes the device, its intended use, and its substantial equivalence to a predicate device. However, this document does not contain information regarding detailed acceptance criteria for the device's performance, nor does it describe specific studies with sample sizes, expert involvement, or ground truth establishment relevant to the request.
The text mentions:
- "Performance testing was conducted to validate the safety and effectiveness of the NuTorque Programmable Electric System."
- "This testing included the electrical safety, electromagnetic compatibility and validation and verification of the software."
- "Testing was completed in accordance with recognized consensus standards."
Based on the provided text, I cannot complete the table or answer the specific questions regarding acceptance criteria, study details, sample sizes, expert qualifications, ground truth, or MRMC studies, as this information is not present in the given document.
The document focuses on demonstrating substantial equivalence to a predicate device (Ti-Max NL400), which is a regulatory pathway that often relies on comparing technical characteristics and intended use rather than requiring extensive clinical performance studies with specific acceptance criteria and validation metrics as might be found for novel diagnostic AI devices.
Therefore, the table below will reflect the absence of the requested information from the provided document.
Acceptance Criteria and Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Not specified in the provided document. | Not specified in the provided document. |
Study Details (Based on provided text)
- Sample size used for the test set and the data provenance: Not specified in the provided document.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not specified in the provided document.
- Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not specified in the provided document.
- If a multi-reader, multi-case (MRMC) comparative effectiveness study was done, and the effect size of how much human readers improve with AI vs. without AI assistance: Not applicable/Not specified in the provided document. This device is a dental handpiece system, not an AI diagnostic tool that would typically involve human reader performance studies.
- If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: Not applicable/Not specified in the provided document. This device is a physical dental instrument system, not a standalone algorithm.
- The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not specified in the provided document for performance testing. The document states "Performance testing was conducted to validate the safety and effectiveness" but does not detail the methodology for establishing ground truth for mechanical/electrical performance.
- The sample size for the training set: Not applicable/Not specified in the provided document. This is not an AI/machine learning device that would have a training set in the typical sense.
- How the ground truth for the training set was established: Not applicable/Not specified in the provided document.
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Image /page/0/Picture/1 description: The image shows the logo for DentalEZ Group. The text "DentalEZ" is in a bold, sans-serif font, with "Dental" on the top line and "EZ" on the same line. Below the "EZ" is the word "GROUP" in a smaller font. A curved line starts below the "G" in "GROUP" and extends up and around the right side of the logo, ending above the "Z" in "EZ".
StarDental Products 1816 Colonial Village Lane Lancaster, PA 17601-5864 717/291-1161 Fax 717/391-2757 www.dentalez.com
510(k) Summary NuTorque Programmable Electric System October 14, 2008
FEB 1 8 2009
1988 1993 3
Company:
DentalEZ Inc., StarDental Division Owner/operator number 2520265
Contact Person:
Dale Braas Quality Manager DentalEZ Inc., StarDental Division 1816 Colonial Village Lane Lancaster, PA 17601 Phone: (717) 291-1161, ext. 4308 Fax: (717) 391-2757
Proprietary/Trade Name:
NuTorque Programmable Electric System
Common/Usual Name:
Dental Handpiece
Classification: ... ..........................................................................................................................................................
Controller, Foot, Handpiece and Cord (per 21 CFR 872.4200)
Predicate Device:
Ti-Max NL400 manufactured by Nakanishi, Inc. Japan. (K011926)
Q. Berner
Image /page/0/Picture/18 description: The image shows the logo for StarDental. The text "StarDental" is written in a bold, sans-serif font. To the right of the text is a stylized star shape, with a portion of the star cut out. The logo is simple and modern.
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Device Description:
The NuTorque Programmable Electric System is an electric handpiece system for use in performing various dental procedures including grinding and trimming. post and pin drilling, pin setting, finishing, polishing, endodontic, caries removal and prophylaxis.
The NuTorque Programmable Electric System is composed of a power supply. control unit, cable and brushless micromotor. The control unit controls the torque, speed and directional rotation of the motor. The system is programmed through the use of a color touch screen on the control unit. The motor has a rotational speed of 100- 40,000 rpm's and can be operated in a clockwise or counterclockwise direction. The system also provides variable light intensity to the handpiece.
Intended Use:
The NuTorque Programmable Electric System is used by trained dental professionals to perform general dental procedures including crown preparation, cavity preparation, crown finishing, inlay and the filling, polishing, prophylaxis and endodontic treatment.
The device is a control unit which drives a low voltage de electric micromotor via a handpiece hose. Power is supplied to the control unit by an ac power supply. The speed of the motor is controlled by the foot control of the dental unit. ISO Etype attachments are used to perform the various procedures. The maximum free run speed of the micromotor is 40,000 rpm's.
Technological Characteristics:
The NuTorque Programmable Electric System is composed of a control unit, power supply, cable and brushless micromotor. The system can be custom programmed with 5 custom settings in the endodontic mode and 3 custom settings in the preparation mode. Within these custom settings there are 27 available gear and torque ratio combinations available. The system also has a demo-mode which allows the operator to verify the selected settings for illumination, fiber optic delay, display contrast, autoreverse-forward and speaker prior to working on the patient. Performance testing was conducted to validate the safety and effectiveness of the NuTorque Programmable Electric System. This testing included the electrical safety, electromagnetic compatibility and validation and verification of the software. Testing was completed in accordance with recognized consensus standards.
StarDental
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Substantial Equivalence:
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The determination of substantial equivalence is based on the premise that the proposed devices and the predicate devices have the same intended use, and similar technology and design. Both devices have the same means of operation and are used for the same procedures.
Image /page/2/Picture/2 description: The image contains the logo for StarDental. The text "StarDental" is written in a bold, sans-serif font, with the word "Star" slightly larger than "Dental". To the right of the text is a stylized star symbol, which is composed of several geometric shapes. The logo is black and white.
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with three stripes representing the three branches of government. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES. USA" is arranged in a circular fashion around the eagle.
Public Health Service
FEB 1 8 2009
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
DentalEZ Incorporated, StarDental Division C/o J.A. Van Vugt KEMA Quality B.V. Utrechtseweg 310 Amhem Netherlands NL-6812 AR
Re: K083252
Trade/Device Name: NuTorque Programmable Electric System Regulation Number: 21 CFR 872.4200 Regulation Name: Dental Handpiece and Accessories Regulatory Class: I Product Code: EBW Dated: February 2, 2009 Received: February 3, 2009
Dear Mr. Braas:
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 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 such 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. Braas
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); 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.
This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification ... The FDA finding of substantial.equivalence.of your device to a legally marketed predicate device results 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 contact the Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0115. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at 240-276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at 240-276-3464. 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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours.
Ginette Y. Michaud, M.D. Acting Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
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Indications for Use
510(k) Number (if known): _ Ko 8325 2
Device Name: NuTorque Programmable Electric System
Indications for Use:
The NuTorque Programmable Electric System is used by trained dental professionals to perform general dental procedures including crown preparation, cavity preparation, crown finishing, inlay and the filling, polishing, prophylaxis and endodontic treatment.
The device is a control unit which drives a low voltage dc electric micromotor via a handpiece hose. Power is supplied to the control unit by an ac power supply. The speed of the motor is controlled by the for control of the dental unit. ISO E-type attachments are used to perform the various procedures. The maximum freerunspeed of the micromotor is 40,000 rpm's.
Prescription I Ise (Sait 2) CFR 801 Subpart D)
Over-The-Counter Use AND/OR . . . (21 CFR: 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Susie Kane
(Division Sign-Off) Division of Anesthesiolory, General Hospital Infection Control, Dental Devices
Page 1 of 1
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.