Dental Low-speed Handpieces and Accessories

{0}------------------------------------------------ Image /page/0/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. September 3, 2021 MicroP Technology (Taiwan), Inc. Ina Lin Official Correspondent No.50, Zhongxiao 2nd St., East District, Chiayi City 60080, Taiwan (R.O.C) Chiayi City, 60080 TAIWAN Re: K202786 Trade/Device Name: Dental Low-speed Handpieces and Accessories Regulation Number: 21 CFR 872.4200 Regulation Name: Dental Handpiece And Accessories Regulatory Class: Class I, reserved Product Code: EFB, EGS Dated: August 18, 2021 Received: August 23, 2021 Dear Ina Lin: 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 statutes and regulations administered by other Federal agencies. You must comply with all the Act's {1}------------------------------------------------ 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/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (OS) 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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems. For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). 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 (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100). Sincerely, Michael E. Adjodha, M.ChE. Assistant Director DHT1B: Division of Dental and ENT Devices OHT1: Office of Ophthalmic, Anesthesia, Respiratory, ENT and Dental Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health Enclosure {2}------------------------------------------------ # Indications for Use 510(k) Number (if known) K202786 #### Device Name Dental Low-speed Handpieces and Accessories Indications for Use (Describe) The Dental Low-speed Handpieces and Accessories are intended for the removal of carious material, reducing hard tooth structure, cavity preparation, finishing tooth preparations, and for polishing teeth. They are designed for use by a trained professional in the field of general dentistry. Type of Use (Select one or both, as applicable) | | <div> <input checked="true" type="checkbox"/> Prescription Use (Part 21 CFR 801 Subpart D) </div> | |--|------------------------------------------------------------------------------------------------------| | | <div> <input type="checkbox"/> Over-The-Counter Use (21 CFR 801 Subpart C) </div> | #### CONTINUE ON A SEPARATE PAGE IF NEEDED. 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." {3}------------------------------------------------ Image /page/3/Picture/0 description: The image shows the logo for MicroP Dental. The logo features an orange geometric shape resembling a stylized letter 'M' or a mountain range. Below the symbol, the text "MicroP DENTAL" is written in a gray, sans-serif font, with "MicroP" in a larger size than "DENTAL". Dental Low-speed Handpieces and Accessories FDA02-05 Page 5-1 # Chapter 5 - 510(k) Summary ## 5.1. Submitter | | 807.92(a) (1) | |----------------|----------------------------------------------------------------------| | Submitter | MicroP Technology (Taiwan), Inc. | | Address | No.50, Zhongxiao 2nd, East Dist., Chiayi City 60080, Taiwan (R.O.C.) | | Contact Person | Ina Lin | | Email | ina.lin@micro-p.com.tw | | Telephone | +886-5-2768238 (Tel.) | | | +886-5-2768272 (Fax) | | Date Prepared | April. 30, 2020 | ### 5.2. Subject Device | | | 807.92(a)(2) | |----------------------------|-----|-------------------------------------------------------| | Trade Name | | Dental Low-speed Handpieces and Accessories | | K-number | | K202786 | | Applicant | | MicroP Technology (Taiwan), Inc. | | Classification Code & Name | EGS | Handpiece, Contra- And Right-Angle Attachment, Dental | | | EFB | Handpiece, Air-Powered, Dental | | Regulation Number | | 872.4200 | | Device Class | | I | #### 5.3. Predicate Devices | Primary Predicate Device | MDK handpieces - Low-speed handpieces | |--------------------------|---------------------------------------| | K-number | K141886 | | Applicant | MODERN KOREA Co., Ltd. | | Classification Name | Dental Handpiece and Accessories | | Regulation Number | 21 CFR 872.4200 | | Classification Code | EFB | | Device Class | 1 | | Reference Device | Codent Low Speed Dental Handpieces and Accessories | |---------------------|----------------------------------------------------| | K-number | K150798 | | Applicant | Codent Technical Industry Co., Ltd. | | Classification Name | Dental Handpiece & Accessories | | Regulation Number | 21 CFR 872.4200 | | Classification Code | EGS | | Device Class | I | | Reference Device | PANA SPRAY Plus | |---------------------|----------------------------------| | K-number | K131014 | | Applicant | NSK AMERICA CORP. | | Classification Name | Dental Handpiece and Accessories | | Regulation Number | 21 CFR 872.4200 | | Classification Code | EFB | | Device Class | 1 | {4}------------------------------------------------ Image /page/4/Picture/0 description: The image shows the logo for MicroP Dental. The logo consists of an orange geometric shape resembling a stylized letter 'M' or a mountain range, positioned above the text 'MicroP' in gray, with 'DENTAL' written in a smaller font size directly below 'MicroP'. The overall design is clean and modern, suggesting a professional and innovative dental company. Dental Low-speed Handpieces and Accessories FDA02-05 Page 5-2 #### 5.4. Reasons for Why We Choose These Predicate Devices We chose the MDK handpieces - Low-speed handpieces to be our primary predicate device because our device is much more similar with this device. However, there are still some differences that we chose Codent Low Speed Dental Handpieces and Accessories to be our reference device. And we chose the PANA SPRAY Plus to be the predicate device because our device composition is similar with this device. For more details, please see our SE comparison table. #### 5.5. Device Description #### 807.92(a)(4) 807.92(a)(3) The low-speed dental handpieces are hand-held instruments driven by air motor or electric motor and relevant gear mechanism, capable of high speed, which is integrated into the head of the handpiece and has a chucking device coaxial with a rotating spindle. The Halley Series includes several models of contra-angle handpieces, straight handpieces, and air motors. The handpieces are intended to be used by well-trained professionals in the field of general dentistry. They are reusable and some have a fiber-optic light system. They are supplied with drive power, water spray, and light through the electric or air motors connected to the tube and dental units. The low-speed handpieces are divided into 4 types: contra-andle handpieces and straight handbieces. with or without fiber-optic. The contra-angle handpieces with fiber optic have 2 models and those without fiber optic have 3 models. The straight handpieces with fiber optic have 1 model and those without fiber optic have 2 models. The handpieces are mainly made of stainless steel and must be reprocessed by the user before first use and after each use. The Halley spray is a special formulated lubricating general handpieces and air-motors. The application ensures well performance and durability for high/low-speed handpieces and air motor. #### 5.6. Indications for Use #### 807.92(a)(5) The Dental Low-speed Handpieces and Accessories is intended for the removal of carious material. reducing hard tooth structure, cavity preparation, finishing tooth preparations, and for polishing teeth. They are designed for use by a trained professional in the field of general dentistry. Halley spray is intended to be used during routine maintenance in order to lubricate Dental Handpieces (including high and low speed) and Dental Air Motors after cleaning and prior to sterilization. #### 5.7. Device Technological Characteristics #### 807.92(a)(6) The Dental Low-speed Handpieces and Accessories is similar in the operating principle, technical data and performance to other low speed dental handpieces currently in the US commercial distribution. Examples of substantially equivalent devices include the MDK handpieces - Low-speed handpieces (K141886) and Codent Low Speed Dental Handpieces and Accessories (K150798). The following table is a comparison of the proposed device to the predicate devices. The Halley spray is similar in the operating principle, technical data and performance to other lubrication spray product in the US commercial currently distribution. Example of substantially equivalent devices PANA SPRAY Plus. The following table is a comparison of the proposed device to the predicate device. {5}------------------------------------------------ Image /page/5/Picture/0 description: The image contains a logo for MicroP Dental. The logo features an orange geometric shape resembling a stylized mountain range or a series of interconnected triangles. Below the geometric shape, the text "MicroP DENTAL" is written in a gray, sans-serif font, with "MicroP" appearing larger and bolder than "DENTAL." # MicroP Technology (Taiwan), Inc. # Dental Low-speed Handpieces and Accessories FDA02-05 Page 5-3 | | | | | Table 5.1_Model List for Handpieces | | | | | |-------------|------------------------|------------------------|--|-------------------------------------------------|--------------------------|---------------------|---------------------|--| | REF | ISO 14457 | | | Ratio | Fiber Optic | | Water Spray | | | Gall | Contra-angle handpiece | | | 1:5 | No | | 4 holes | | | Gazi | Contra-angle handpiece | | | 1:5 | Yes | 4 holes | | | | G25 | | Contra-angle handpiece | | 1:1 | No | | 4 holes | | | G25L | | Contra-angle handpiece | | 1:1 | Yes | | 4 holes | | | G23 | | Contra-angle handpiece | | 1:1 | No | External irrigation | | | | G65 | | Straight handpiece | | 1:1 | No | 4 holes | | | | Geer | | Straight handpiece | | 1:1 | Yes | 4 holes | | | | G63 | | Straight handpiece | | 1:1 | No | | External irrigation | | | | | | | Table 5.2_Model List for Air Motors | | | | | | REF. | ISO 14457 | Coupling | | Hose Connector | Fiber Optic | | Water Spray | | | G205-M4 | Air motor | ISO 3964 Type E | | 4 holes (ISO 9168 Type 2) | No | | External irrigation | | | G205-B2 | Air motor | ISO 3964 Type E | | 2 holes (ISO 9168 Type 1) | No | | External irrigation | | | | REF. | | | Table 5.2_Model List for Lubricant Spay<br>Size | | | Volume | | | | AHZZ009 | | | Large | 600 mL | | | | | | AHZZ011 | | | Small | | | 300 mL | | | | | | | | | | | | | Code: FDA02 | | Version: C | | Revision Status: 0 | Issuing Date: 2021/08/10 | | | | {6}------------------------------------------------ Image /page/6/Picture/0 description: The image features a logo for MicroP Dental. The logo consists of an orange geometric shape resembling a stylized letter 'M' or a mountain peak. Below the shape, the text 'MicroP DENTAL' is written in a gray, sans-serif font, with 'MicroP' in a larger size than 'DENTAL'. The overall design is simple and modern, suggesting a professional and reliable dental service. # MicroP Technology (Taiwan), Inc. Dental Low-speed Handpieces and Accessories FDA02-05 Page 5-4 | Product Type | Contra-angle Handpieces | | | | | Straight Handpieces | | | |----------------------------------------|----------------------------------------------------------------------------------------|-----------|---------------------------------------|-----------|---------------------|---------------------------------------|---------------------|-----| | Model | G95 | G95L | G25 | G25L | G23 | G65 | G65L | G63 | | Color Coding | Red | | Blue | | | | | | | Max Rotation Speed | 200,000 rpm | | 40,000 rpm | | | | | | | Gear Ratio | 1:5 (Increasing) | | 1:1 (Direct Drive) | | | | | | | Water Spray Type | Internal 4-hole spray | | | | External irrigation | Internal 4-hole spray | External irrigation | | | Fiber Optic | N/A | Glass Rod | N/A | Glass Rod | N/A | N/A | Glass Rod | N/A | | Water Consumption | >50 mL (0.1 MPa) | | | | | | | | | Bur Type | FG Bur (EN ISO 1797-1 Type 3 Ø1.60mm) | | CA Bur (EN ISO 1797-1 Type 1 Ø2.35mm) | | | HP Bur (EN ISO 1797-1 Type 2 Ø2.35mm) | | | | Chip Air Consumption | Min. 1.5 NL/min (0.2 MPa) | | | | | | | | | Water Consumption | Min. 50 mL/min (0.2 MPa) | | | | | | | | | Max. Working Part Diameter | Ø2.0 mm | | Ø4.0 mm | | | | | | | Transportation and Storage Environment | Temperature: -10 - 50°C<br>Humidity: 10 - 85%<br>Atmospheric Pressure: 500 - 1,060 hPa | | | | | | | | {7}------------------------------------------------ Image /page/7/Picture/0 description: The image shows the logo for MicroP Dental. The logo features a stylized orange symbol resembling a mountain range or a stylized letter 'M' at the top. Below the symbol, the text "MicroP DENTAL" is written in a gray, sans-serif font, with "MicroP" in a larger size than "DENTAL". # MicroP Technology (Taiwan), Inc. Dental Low-speed Handpieces and Accessories | Table 5.6 General Specification for Lubricant Spray | | | | | | | | |-----------------------------------------------------|------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------|--------------------------------------|--|--|--| | Product Type | | Small Spray can | Large Spray can | | | | | | Volume | | 300 mL | 600 mL | | | | | | Propellant | | Butane | | | | | | | Content | | White Mineral Oil, Ethyl Alcohol | | | | | | | Color | | Transparent | | | | | | | Purpose | | For lubrication of dental handpieces, contra-angles, turbines, heads and air<br>motors | | | | | | | | Table 5.7_Comparison Table<br>Codent Low Speed | | | | | | | | Descriptive<br>Information | | Dental Low-speed Handpieces and Accessories | MDK Low-speed<br>handpieces | Dental Handpieces<br>and Accessories | | | | | 510(k) Number | | K202786 | K141886 | K150798 | | | | | Indications for use | the field of general dentistry. | MicroP Dental Low-speed Handpieces and Accessories is<br>intended for removing carious material, excess filling material,<br>cavity and crown preparation, finishing tooth preparations and<br>restorations, root canal preparations and polishing teeth. All<br>the devices are designed for use by a trained professional in | Simliar | Simliar | | | | | Operational Modes | | Air-powered | Identical | Identical | | | | | Type of chuck | | Push button | Push button, latch,<br>screw, snap-on or tip-<br>lock chuck options | Identical | | | | | Composition of<br>Main Materials | Stainless Steel, Aluminum Alloy | | Stainless Steel,<br>Titanium | Identical | | | | | Operating<br>pressure | 36psi to 43 psi | | Identical | Information not<br>available | | | | | Motor Speed | Up to 25,000 rpm | | Up to 20,000 rpm | Identical | | | | | MicroP Halley Spray<br>Lubricant | | | Pana-Spray made by<br>NSK(K052700) | Information not<br>available | | | | | Sterilization | | Steam autoclave method | Identical | Identical | | | | | Compliance to<br>Standards | | Complied with ISO 10993-5, ISO 10993-10, ISO14457 | Identical | Information not<br>available | | | | ### Table 5.8_Comparison Table of Spray | Descriptive<br>Information | Halley Spray | PANA SPRAY Plus | SE Comparison | |--------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------| | 510(k) Number | K202786 | K131014 | | | Indications for use | <i>Halley Spray</i> is intended to be used during<br>routine maintenance in order to lubricate<br>Dental Handpieces (including low speed<br>and high speed) and Dental Air Motors<br>after each patient use and prior to<br>sterilization. | <i>PANA SPRAY Plus</i> is a lubricant intended<br>to be used during routine maintenance of<br>dental and surgical handpieces after each<br>patient use and prior to sterilization. | Similar | | Components name/ Weight percentage (% w/w) | | | | | Lubricant | 10.0 - 20.0% | 5.0 - 10.0% | Different | | Ethanol | 15.0 - 25.0% | 25.0 - 35.0% | Different | | Propellant | 50.0 - 80.0% | 45.0 - 75.0% | Different | Code: FDA02 Version: C Revision Status: 0 Issuing Date: 2021/08/10 {8}------------------------------------------------ Image /page/8/Picture/0 description: The image shows a logo for MicroP Dental. The logo features an orange geometric shape resembling a stylized letter 'M' or a mountain range above the text 'MicroP' in a bold, gray font. Below 'MicroP' is the word 'DENTAL' in a smaller, bolder, gray font. Dental Low-speed Handpieces and Accessories 807.92(b)(2) | <b>5.8. Non-clinical Testing Summary</b> | <b>807.92(b) (1)</b> | |------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------| | The Dental Low-speed Handpieces and Accessories was developed taking into consideration all applicable technical standards, internal specifications and FDA guidance documents. The Dental Low-speed Handpieces and Accessories in compliance with the applicable international and internal standards was verified through bench testings. | | | The following standards were considered: | | | ISO 14457, Dentistry — Handpieces and motors ISO 1797, Dentistry -- Shanks for rotary and oscillating instruments ISO 5349-1, Mechanical vibration — Measurement and evaluation of human exposure to hand-transmitted vibration — Part 1: General requirements ISO 9168, Dentistry — Hose connectors for air driven dental handpieces IEC 62366, Medical devices — Application of usability engineering to medical devices ISO 10993-1, Biological evaluation of medical devices — Part 1: Evaluation and testing within a risk management process ISO 10993-5, Biological evaluation of medical devices — Part 5: Tests for in vitro cytotoxicity ISO 10993-10, Biological evaluation of medical devices — Part 10: Tests for irritation and skin sensitization ISO 17664 Sterilization of medical devices — Information to be provided by the manufacturer for the processing of resterilizable medical devices ISO 17665-1 Sterilization of health care products — Moist heat — Part 1: Requirements for the development, validation and routine control of a sterilization process for medical devices | Version 2017 2017 2001 2009 2007 2018 2009 2010 2017 2006 | ## 5.9. Clinical Testing Summary Clinical testing has not been performed. ## 5.10. Conclusion 807.92(b)(3) Based upon the comparison of technological characteristics, demonstrated through bench testing and intended use, the Dental Low-speed Handpieces and Accessories is substantially equivalent to the predicate devices. | Code: | FDA02 | |------------------|------------| | Version: | C | | Revision Status: | 0 | | Issuing Date: | 2021/08/10 |