General Cutting Contra Handpiece

{0}------------------------------------------------ | Submitter | NAKANISHI INC.<br>700 Shimohinata<br>Kanuma-Shi, Tochigi-Ken Japan 322-8666 | | | |------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------|-----------------------------------------------| | Contact<br>Person | Mr. Kimihiko Satoh<br>General Manager, Regulatory Affairs, R&D Division<br>TEL: +81-289-64-3380<br>FAX: +81-289-62-6665<br>k-satoh@nsk-nakanishi.co.jp | | | | Date Prepared | April 15, 2019 | | | | Trade Name | General Cutting Contra Handpiece | | | | Common<br>Name | Handpiece, Contra-And Right-Angle Attachment, Dental | | | | Classification<br>Name | Dental Handpiece and Accessories | | | | Product Code | EGS | Class I | 872.4200 | | Predicate<br>Device | K972569 | NAKANISHI INC. | E-Type Speed Increaser<br>Contra Angle, ES-95 | | Reference<br>Devices | K113655 | NAKANISHI, INC. | Ti-Max X Turbine | | | K073652 | NAKAMURA | ND LOWSPEED<br>AIRMOTOR | | Device<br>Description | The General Cutting Contra Handpiece features an allowable maximum motor<br>speed at $40,000 min^{-1}$ . The handpieces are provided optic and non-optic and are<br>designed with a contra-angle appearance. Models are available to be connected<br>directly onto motors compliant to ISO 3964. Available handpieces include the<br>S-Max M Contra Series, Ti-Max X Contra Series, Ti-Max Z Contra Series and<br>the Ti-Max nano Series. | | | | Indications for<br>Use | The General Cutting Contra Handpiece is powered by either an air-motor or<br>electronic micromotor for use in general dentistry. The device is intended for<br>cutting and grinding teeth, cavity preparations, tooth and crown preparations,<br>finishing and trimming teeth and filling materials and removal of crowns and<br>filling materials. | | | | Summary of<br>Technological<br>Characteristics | As with the predicate devices referenced above, the General Cutting Contra<br>Handpiece is intended for dental treatment. The handpieces are powered by<br>either an air-motor or electronic micro motors compliant to ISO 14457 with<br>couplings compliant to [ISO 3964 (EN ISO 3964)]. Friction Grip Burs and<br>Contra Angle Burs that conform to ISO 1797-1 (EN ISO 1797) are to be used<br>with the General Cutting Contra Handpiece. The allowable maximum motor<br>speed rotation for the handpieces is at $40,000 min^{-1}$ . The handpieces are available | | | Image /page/0/Picture/2 description: In the image, a hand wearing a white glove is holding a blue plastic tool. The tool has a unique design with sharp edges and points. The words "Powerful Partners" are written at the bottom of the image. The hand is holding the tool in a way that suggests it is being used for a precise task. {1}------------------------------------------------ with fiber optic and non-optic. All models include a water spray feature. The General Cutting Contra Handpiece is provided non-sterile, so it must be sterilized prior to first use and sterilized after each subsequent use using steam sterilization (moist heat sterilization). The proposed device shares technological characteristics with the predicate device. The proposed device also has some differences in technological characteristics from those of the predicate device. Any differences in the technological characteristics are minor and reflect market strategy and/or perceived user preferences. | | Proposed Device:<br>NAKANISHI INC.<br>[K182999] | Predicate Device:<br>NAKANISHI INC.<br>[K972569] | Reference Device:<br>NAKANISHI INC.<br>[K113655] | Reference Device:<br>NAKAMURA<br>DENTAL<br>[K073652] | Coupling<br>Type | ISO 3964 (EN ISO<br>3964) Standard<br>Coupling | ISO 3964 Standard<br>Coupling | Nakanishi (NSK),<br>KaVo, W&H, Bien<br>Air, Sirona | ISO 3964 Standard<br>Coupling | |---------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------| | Trade<br>Name | General Cutting<br>Contra Handpiece | E-Type Speed<br>Increaser Contra<br>Angle, ES-95 | Ti-Max X Turbine<br>Series | ND E-TYPE<br>CONTRAANGLE | Burs | ISO 1797-1 (Type1)<br>ISO 1797-1 (Type3) | ISO-1797-1 (Type<br>3)<br>(1.6mm<br>or .0630in) | ISO 1797-1 Type 3 | EC-20L : ISO 1797-1<br>(Type1)<br>EC-30BL: ISO 1797-1<br>(Type1)<br>EG-20L : ISO 1797-1<br>(Type1)<br>EGG-20L:Unknown | | Model<br>Numbers | S-Max M:<br>M15L, M15, M25L,<br>M25, M95L, M95<br>Ti-Max X:<br>X10L, X10, X12L,<br>X12, X15L, X15,<br>X20L, X20, X25L,<br>X25, X85, X85L, X95,<br>X95L<br>Ti-Max Z:<br>Z10L, Z15L, Z25L,<br>Z85L, Z95L<br>Ti-Max nano:<br>nano15LS, nano25LS,<br>nano95LS | ES-95 | Miniature Head:<br>X500; X500L;<br>X500K; X500KL;<br>X500SL; X500WL;<br>X500BL<br>Standard Head:<br>X600; X600L;<br>X600K; X600KL;<br>X650L; X650KL;<br>X600SL; X600WL;<br>X600BL;<br>X600WLED;<br>X600BLED<br>Torque Head:<br>X700; X700L;<br>X700K : X700KL:<br>X700SL; X700WL;<br>X700BL; | EC-20L<br>EC-30BL<br>EG-20L<br>EGG-20L | Max<br>Rotation<br>Speed<br>(motor) | $40,000min^{-1}$ max | $40,000min^{-1}$ max | Miniature Head:<br>(500): 390,000 –<br>450,000<br>Standard Head:<br>(600): 380,000 –<br>440,000<br>Torque Head:<br>(700): 300,000 –<br>360,000 | EC-20L : $20,000min^{-1}$<br>EC-<br>30BL : $30,000min^{-1}$<br>EG-20L : $20,000min^{-1}$<br>EGG-20L:Unknown | | Indication<br>for Use | The General Cutting<br>Contra Handpiece is<br>powered by either an<br>air-motor or electronic<br>micromotor for use in<br>general dentistry. The<br>device is intended for<br>cutting and grinding<br>teeth,<br>cavity<br>preparations, tooth and<br>crown preparations,<br>finishing and trimming<br>teeth and filling<br>materials and removal<br>of crowns and filling<br>materials. | The device is<br>intended for use<br>where high speed<br>such as 200,000 rpm<br>is required in general<br>dentistry with or<br>without use of<br>coolant; such as<br>cutting a tooth for<br>cavity and/or crown<br>preparation and<br>finishing, cutting<br>and/or finishing of<br>dentures, denture<br>bases, crowns, inlays<br>and metal plates.<br>The device is driven<br>by an electrical<br>micrometer or an air<br>motor handpiece that<br>has the ISO-3964<br>coupling. | The Ti-Max X Series<br>is an air-powered<br>dental handpiece<br>intended for removing<br>carious material,<br>reducing hard tooth<br>structure, cavity<br>preparation, finishing<br>tooth preparations and<br>restorations and<br>polishing teeth. | ND e-type contra p is<br>powered by either low<br>speed air-motor or<br>electric micromotor<br>for removing carious<br>material and excess<br>filling material, cavity<br>and crown<br>preparation, root | Gear Ratio<br>Max<br>rotation<br>speed<br>(handpiece) | 16:1 Reduction-<br>$2,500min^{-1}$<br>10:1 Reduction-<br>$4,000min^{-1}$<br>4:1 Reduction-<br>$10,000min^{-1}$<br>1:1 Direct Drive-<br>$40,000min^{-1}$<br>1:5 Increasing-<br>$200,000min^{-1}$ | 1:5 Increasing-<br>$200,000min^{-1}$ | N/A | 16:1 Reduction:<br>Unknown<br>4:1 Reduction:<br>$5,000min^{-1}$<br>1:1 Direct Drive:<br>$30,000min^{-1}$ | | Weight | 53.5g - 78.5g | 62.5 g | 36.7 – 52.5g | Unknown | Cleaners/<br>Lubricants | NSK PANA SPRAY<br>Plus (K163483) | Mineral Oil | Care3 Plus automatic<br>handpiece<br>cleaning/lubrication<br>tabletop unit<br>[K081811] | YOSHIDA<br>Lubrication Oil Spray | | Sterilization<br>Method | Steam Autoclave<br>(Moist Heat) | Steam Autoclave<br>(Moist Heat) | Steam Autoclave<br>(Moist Heat) | Steam Autoclave<br>(Moist Heat) | | | | | | | Sterilization<br>Standard | ANSI/AAMI/ISO<br>17665-1:2006 | ISO 17665-1 | EN ISO 17665-<br>1:2006 | Unknown | | | | | | Image /page/1/Picture/4 description: The image shows a hand wearing a white glove holding a blue object with the text "Powerful Partners" below. The blue object appears to be a stylized logo or design element. The hand is positioned in a way that suggests it is presenting or showcasing the blue object. The background is plain, drawing attention to the hand and the blue object. NAKANISHI INC. Headquarters : 700 Shimohihata Kanuma-shi Tochigi 322-8666, Japan www.nsk-inc.com Tokyo Office : MY Building 1-13-3 Ueno Taito-ku Tokyo 110-0005, Japan {2}------------------------------------------------ NSK Summary of Performance Testing The General Cutting Contra Handpiece was developed and is produced under considerations of all applicable technical standards, internal specifications, and FDA guidance documents. The product's conformance with applicable international and internal standards was verified in the course of bench testing. Tests were performed on the handpiece including verification/validation testing to internal functional specifications which demonstrated that the device is substantially equivalent and complies with FDA requirements stated in Guidance Document "Dental Handpieces - Premarket Notification [510(k)] Submissions - Guidance for Industry and FDA Staff'. Sterilization has been validated in conformance to the FDA recognized consensus standard AAMI/ANSI/ISO 17665-1:2006; "Sterilization of Health Care Products – Moist Image /page/2/Picture/4 description: In the image, a hand wearing a white glove is holding a blue surgical instrument. The instrument has a unique design with sharp edges and angles. The words "Powerful Partners" are visible at the bottom of the image. Section 5: Page 3 of 4 {3}------------------------------------------------ Image /page/3/Picture/0 description: The image shows the logo for NSK, a Japanese manufacturer of bearings. The logo is white and is set against a blue background. The letters "NSK" are in a bold, sans-serif font, with the top of the "N" extending over the "S" and "K". Heat - Part 1: Requirements for the Development, Validation, and Routine Control of a Sterilization Process for Medical Devices." Documentation was provided demonstrating that the General Cutting Contra Handpiece complies with the FDA requirements stated in Guidance for the "Reprocessing Medical Devices in Health Care Settings: Validation Methods and Labeling - Guidance for Industry and Food and Drug Administration Staff". Biocompatibility evaluations were selected in accordance with AAMI/ANSI/ISO 10993-1: "Biological evaluation of medical devices - Part 1: Evaluation and testing" and FDA Guidance "Use of International Standard ISO 10993-1, "Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process- Guidance for Industry and Food and Drug Administration Staff". In addition, testing for electrical safety was performed in accordance with ISO 14457. - NAKANISHI, INC. considers the General Cutting Contra Handpiece to be Conclusion substantially equivalent to the predicate devices listed above. This conclusion is based on the similarities in primary intended use, principles of operation, functional design, and established medical use. Image /page/3/Picture/3 description: The image shows a hand wearing a white glove holding a blue surgical instrument. The instrument has a sleek, modern design with sharp edges and a pointed tip. The words "Powerful Partners" are written in a small font at the bottom of the image. {4}------------------------------------------------ # Indications for Use 510(k) Number (if known) K182999 Device Name General Cutting Contra Handpiece # Indications for Use (Describe) The General Cutting Contra Handpiece is powered by either an air-motor or electronic micromotor for use in general dentistry. The device is intended for cutting and grinding teeth, cavity preparations, tooth and crown preparations, finishing and trimming teeth and filling materials and removal of crowns and filling materials. Type of Use (Select one or both, as applicable) 2 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. ## FOR FDA USE ONLY Concurrence of Center for Devices and Radiological Health (CDRH) (Signature) This section applies only to requirements of the Paperwork Reduction Act of 1995. ## *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW!* The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to: > Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov "An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number." {5}------------------------------------------------ Image /page/5/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue. April 16, 2019 Nakanishi Inc. % Katie Reneson Regulatory Specialist Ken Block Consulting 800 East Campbell Road, Suite 202 Richardson, Texas 75081 Re: K182999 Trade/Device Name: General Cutting Contra Handpiece Regulation Number: 21 CFR 872.4200 Regulation Name: Dental Handpiece And Accessories Regulatory Class: Class I Product Code: EGS Dated: March 15, 2019 Received: March 18, 2019 Dear Katie Reneson: 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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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. 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 {6}------------------------------------------------ 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 of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.htm); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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 comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100). Sincerely, for Tina Kiang, Ph.D. Acting Director Division of Anesthesiology, General Hospital, Respiratory, Infection Control, and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure