Who is the manufacturer of High-speed air turbine handpiece / Low-speed air turbine handpiece?

Foshan Wenjian Medical Instrument Co., Ltd. filed the 510(k) submission for High-speed air turbine handpiece / Low-speed air turbine handpiece (K181691).

What is the FDA product code for High-speed air turbine handpiece / Low-speed air turbine handpiece?

EFB. It is classified under 21 CFR 872.4200 as a Class 1 device in the Dental panel.

What is the regulatory pathway for High-speed air turbine handpiece / Low-speed air turbine handpiece?

510(k) clearance (submission type: Traditional).

What are the predicate devices for High-speed air turbine handpiece / Low-speed air turbine handpiece?

Dental High-speed Turbine Handpiece (K170229).

Who can help prepare an FDA 510(k) submission like High-speed air turbine handpiece / Low-speed air turbine handpiece?

Innolitics — a medical-device software consultancy — provides regulatory and engineering support for FDA 510(k) submissions. See https://innolitics.com/services/510ks/ or contact https://innolitics.com/contact.

High-speed air turbine handpiece / Low-speed air turbine handpiece

K181691 · Foshan Wenjian Medical Instrument Co., Ltd. · EFB · May 26, 2020 · Dental

Device Facts

Record ID	K181691
Device Name	High-speed air turbine handpiece / Low-speed air turbine handpiece
Applicant	Foshan Wenjian Medical Instrument Co., Ltd.
Product Code	EFB · Dental
Decision Date	May 26, 2020
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 872.4200
Device Class	Class 1
Attributes	Therapeutic

Intended Use

Dental High-speed Turbine Handpiece (WJ-112, WJ-124, WJ-122, WJ-134, WJ-132, WJ -144, WJ -142, WJ -154, WJ -152, WJ -164, WJ -162) is intended for removing carious material, excess filling material, cavity and crown preparation, finishing tooth preparations and restorations, root canal preparations and polishing teeth. Dental Low-speed Turbine Handpiece (WJ-414, WJ-412, WJ-422) is intended for removing carious material, excess filling material, cavity and crown preparation, finishing tooth preparations and restorations, root canal preparations and polishing teeth.

Device Story

High-speed and low-speed air turbine handpieces for dental clinic/hospital use; operated by dental professionals. High-speed models (WJ-1XX series) operate at 300,000–400,000 rpm; low-speed models (WJ-4XX series) include air motor, straight, and geared angle handpieces with variable gear ratios (1:1, 20:1, 1:5) and speeds up to 22,000 rpm. Devices connect to dental unit tubes via 2-hole or 4-hole couplings. Input is compressed air/water; output is mechanical rotation for drilling, grinding, and polishing. Requires routine maintenance with specified lubricant (PANA SPRAY Plus). Sterilizable via steam at 135°C. Assists clinicians in tooth disease treatment and restorative procedures.

Clinical Evidence

Bench testing only. Performance verified per ISO 14457:2012. Biocompatibility testing (cytotoxicity, sensitization, irritation) per ISO 10993-5 and ISO 10993-10. Electrical safety per IEC 60601-2-60. Sterilization and cleaning validation per ISO 17665-1, ISO 17665-2, and ASTM ST79.

Technological Characteristics

Materials: stainless steel, brass, aluminum, titanium. Energy: compressed air. Speed: 300k-400k rpm (high-speed), up to 22k rpm (low-speed). Connectivity: 2-hole or 4-hole coupling (ISO 3964). Sterilization: steam (135°C). Standards: ISO 14457, ISO 10993, IEC 60601-1, IEC 80601-2-60, ISO 17665, ISO 17664.

Indications for Use

Indicated for dental professional use in removing carious material, excess filling material, cavity and crown preparation, finishing tooth preparations and restorations, root canal preparations, and polishing teeth.

Regulatory Classification

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.

Predicate Devices

Dental High-speed Turbine Handpiece (K170229)

Reference Devices

Dental Low-speed Turbine Handpiece (K170236)
MDK Handpieces (K141886)

Related Devices

K170229 — Dental High-speed Turbine Handpiece · Guangdong Jinme Medical Technology Co., Ltd. · Nov 8, 2017
K251388 — Dental air-motor handpiece (TM-203B2, TM-203M4, TM-205B2, TM-205M4, TM-IS, TM-ES, TM-SG20, TM-X25, TM-BB, TM-IC, TM-RA41) · Foshan Topmed Dental Co., Ltd. · Jan 12, 2026
K170236 — Dental Low-speed Turbine Handpiece · Guangdong Jinme Medical Technology Co., Ltd. · Nov 21, 2017
K251389 — High speed air turbine handpiece · Foshan Topmed Dental Co., Ltd. · Jan 12, 2026
K240337 — Dental Handpiece (Model: J6-126, J6-136, SH11W2, SH11W3, W401LW, W15LW, W142LW, W11L) · Guangdong Jinme Medical Technology Co., Ltd. · Nov 13, 2024

Submission Summary (Full Text)

{0}------------------------------------------------ Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo is a blue square with the letters "FDA" in white, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue. May 26, 2020 Foshan Wenjian Medical Instrument Co., Ltd. % Cassie Lee Manager Guangzhou GLOMED Biological Technology Co., Ltd. Suite 306, Kecheng Mansion, No.121 Science Road, Guangzhou Science Park Guangzhou, Guangdong, 510663 CHINA Re: K181691 Trade/Device Name: High-speed air turbine handpiece / Low-speed air turbine handpiece Regulation Number: 21 CFR 872.4200 Regulation Name: Dental Handpiece and Accessories Regulatory Class: Class I, reserved Product Code: EFB, EGS Dated: April 9, 2020 Received: April 27, 2020 Dear Cassie Lee: 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, for Srinivas "Nandu" Nandkumar, Ph.D. Director DHT1B: Division of Dental 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) K181691 ### Device Name High-speed air turbine handpiece / Low-speed air turbine handpiece Indications for Use (Describe) Dental High-speed Turbine Handpiece (WJ-114, WJ-122, WJ-124, WJ-134, WJ-132, WJ-144, WJ-142, WJ -154, WJ -162, WJ -162) is intended for removing carious material, excess filling material, cavity and crown preparation, finishing tooth preparations and restorations, root canal preparations and polishing teeth. Dental Low-speed Turbine Handpiece (WJ-414, WJ-424, WJ-422) is intended for removing carious material, excess filling material, cavity and crown preparations and restorations and restorations, root canal preparations and polishing teeth. | Type of Use (Select one or both, as applicable) | | |-----------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------| | \u2612 Prescription Use (Part 21 CFR 801 Subpart D) | \u2610 Over-The-Counter Use (21 CFR 801 Subpart C) | ## 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}------------------------------------------------ # K181691 ### 510(k) Summary Date Prepared: May 22, 2020 # 1. Submitter's Information Name of Sponsor: Foshan Wenjian Medical Instrument Co., Ltd. Address: Third Floor, No.3, Jiebian Industrial Zone, LuoCun, ShiShan Town, Nanhai, Foshan City, Guangdong, China Contact Name (Title): Wen Huang (Manager) Telephone No.: 86-757-81801258 Email: 1191837402@gqq.com ## Application Correspondent: Contact Person: Ms. Cassie Lee Guangzhou GLOMED Biological Technology Co., Ltd. Address: Suite 306, Kecheng Mansion, No.121 Science Road, Guangzhou Science Park, Guangzhou 510663, China Tel: +86-20-61099984 Email: regulatory@glomed-info.com # 2. Subject Device Information: Common Name: Dental Handpiece and Accessories Trade Name: High-speed air turbine handpiece / Low-speed air turbine handpiece Model: Dental High-speed Turbine Handpiece (WJ-114, WJ-112, WJ-122, WJ-134, WJ-134, WJ -144, WJ -142, WJ -154, WJ -152, WJ -164, WJ -162) Dental Low-speed Turbine Handpiece (WJ-414, WJ-412, WJ-422) Classification Name: Dental Handpiece and Accessories Review Panel: Dental Product Code: EFB, EGS Regulation Class: 1 Regulation Number: 21 CFR 872.4200 # 3. Predicate Device Information: ## Primary Predicate: (K170229) Company Name: Guangdong JINME Medical Technology Co., Ltd. Common Name: Dental Handpiece and Accessories Trade Name: Dental High-speed Turbine Handpiece Product Code: EFB Regulation Class: 1 # Reference Device 1: (K170236) {4}------------------------------------------------ Company Name: Guangdong JINME Medical Technology Co., Ltd. Common Name: Dental Handpiece and Accessories Trade Name: Dental Low-speed Turbine Handpiece Product Code: EFB, EGS Regulation Class: 1 # Reference Device 2: (K141886) Company Name: Modern Korea Co., Ltd. Trade Name: MDK Handpieces Classification Name: Dental Handpiece and Accessories Product Code: EFB Regulation Class: 1 # 4. Device Description #### � Dental High-speed Turbine Handpiece The Dental High-speed Turbine Handpiece is the dental clinic, hospital treatment for patients with tooth disease tools, which is an instrument for drilling, grinding, repairing. It composed of handpiece and a connector, including models WJ-114, WJ-112, WJ-124, WJ-134, WJ-132, WJ-144, WJ -142, WJ -154, WJ -152, WJ -164, WJ -162. For the model name which including: WJ represent for branch name. WJ-1XX represent for Dental High-speed Turbine Handpiece; WJ-XX2 represent for model which included 2-hole (drive air and water holes); WJ-XX4 represent for model which included 4-hole coupling (drive air, exhaust air, spray air and spray water holes); Handpiece are able to run 300000 to 400000 rpm. Handpiece and adaptors can bear steam disinfection at 135°C. The scope of application: for dental professional use only. Lubricant should be used during routine maintenance (e.g. after each patient use and prior to sterilization). In order to avoid the risk, user must buy and use specified lubricant type "PANA SPRAY Plus" manufactured by NAKANISHI INC (cleared in K163483). #### � Dental Low-speed Turbine Handpiece The Dental Low-speed Handpiece is the dental clinic, hospital treatment for patients with tooth disease tools, which is an instrument for drilling, grinding, repairing. It composed of handpiece and a connector, including low speed air motor, straight handpiece and geared angle handpiece, for the model WJ-414, WJ-412, WJ-424, WJ-422 {5}------------------------------------------------ The gear ratios of handpieces have a various gear ratio (for different geared angle handpiece) (1:1 (constant), 20:1 (speed reduction) and 1:5 (speed increase)); The handpieces have maximum Forward rotation speed 19000 rpm and maximum Reverse rotation speed of 18000 rpm. The air motors are capable of running up to a speed of 22000 rpm, but different pressure of air supply. Handpiece and adaptors can bear steam disinfection at 135°C. Coupling is the accessory for handpiece to connect with tubes of dental unit. It could be divided into three types. It included 2-hole (drive air and water holes) and 4-hole coupling (drive air, exhaust air, spray air and spray water holes). The use of the coupling of handpiece is due to the number of tubes of dental unit. The scope of application: for dental professional use only. Lubricant should be used during routine maintenance (e.g. after each patient use and prior to sterilization). In order to avoid the risk, user must buy and use specified lubricant type "PANA SPRAY Plus" manufactured by NAKANISHI INC (cleared in K163483). # 5. Intended Use / Indications for Use Dental High-speed Turbine Handpiece (WJ-112, WJ-124, WJ-122, WJ-134, WJ-132, WJ -144, WJ -142, WJ -154, WJ -152, WJ -164, WJ -162) is intended for removing carious material, excess filling material, cavity and crown preparation, finishing tooth preparations and restorations, root canal preparations and polishing teeth. Dental Low-speed Turbine Handpiece (WJ-414, WJ-412, WJ-422) is intended for removing carious material, excess filling material, cavity and crown preparation, finishing tooth preparations and restorations, root canal preparations and polishing teeth. # 6. Test Summary High-speed air turbine handpiece / Low-speed air turbine handpiece is designed, tested and will be manufactured in accordance with both mandatory and voluntary standards. Performance testing was provided including: - Cytotoxicity, sensitization, and irritation biocompatibility test according to ISO 10993-5 and ISO 10993-10 standards - Performance test according to ISO 14457:2012 standards. - Medical electrical equipment test according to IEC 60601-2-60 standards - Sterilization and cleaning validation per ISO 17665-1, ISO 17665-2, ASTM ST79, and the FDA Guidance Document "Reprocessing Medical Devices in Health Care Settings: Validation Methods and Labeling" {6}------------------------------------------------ The result of tests indicates that the Dental Handpiece and Accessories has substantial equivalent performance as the legally marketed predicate device. | Elements of Comparison | Subject Device | Primary Predicate | Reference Device 1 | Reference Device 2 | Remark | |----------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------| | Manufactur er | Foshan Wenjian Medical Instrument Co., Ltd. | Guangdong JINME Medical Technology Co., Ltd. | Guangdong JINME Medical Technology Co., Ltd. | Modern Korea Co. Ltd. | -- | | Device Name | High-speed air turbine handpiece / Low-speed air turbine handpiece | Dental High- speed Turbine Handpiece | Dental Low- speed Turbine Handpiece | MDK Handpieces | -- | | Model | Dental High-speed Turbine Handpiece (WJ-114, WJ- 112, WJ-124, WJ -122, WJ- 134, WJ -132, WJ - 144, WJ -142, WJ -154, WJ - 152, WJ -164, WJ -162) Dental Low-speed Turbine Handpiece (WJ-414, WJ- 412, WJ-424, WJ-422) | T, S, M, TU, SU, MU, TP, SP, TUQ, TUP, SUP, SUQ, TUL, SUL, TUQL, SUQL, TUQP, SUQP, 45- T,45-TU,45- TUQ | LN, L | -- | -- | | 510(k) Number | K181691 | K170229 | K170236 | K141886 | -- | | Product Code | EFB, EGS | EFB | EFB, EGS | EFB | SE | | Indications for Use& Intended Use | Dental High-speed Turbine Handpiece (WJ-114, WJ- 112, WJ-124, WJ -122, WJ- 134. WJ -132. WJ - 144, WJ -142, WJ -154, WJ - 152, WJ -164, WJ -162) is intended for removing carious material, excess filling material, cavity and crown preparation, finishing tooth preparations and restorations, root canal preparations and polishing teeth. Dental Low-speed | Dental High- speed Turbine Handpiece is intended for removing carious material, excess filling material, cavity and crown preparation, finishing tooth preparations and restorations, root canal preparations and polishing teeth. | Dental Low- speed Turbine Handpiece is intended for removing carious material, excess filling material, cavity and crown preparation, finishing tooth preparations and restorations, root canal preparations and polishing teeth. | MDK high- speed handpieces are used for the removal of carious material, reducing of hard tooth structure, cavity and crown preparations, removal of fillings, processing and finishing tooth preparations, restorations, | SE Note 1 | | | | | | | | | | Turbine Handpiece (WJ-414, WJ- 412, WJ-424, WJ-422) is intended for removing carious material, excess filling material, cavity and crown preparation, finishing tooth preparations and restorations, root canal preparations and polishing teeth. | | | and for polishing teeth. MDK low- speed handpieces used for teeth cutting, cavity and crown preparation, restorations and polishing teeth. All the devices are designed for use by a trained professional in the field of general dentistry. | | | Air/water ports | 2/4 ports | 2/4 ports | 2/4 ports | Up to four | SE | | Fiberoptic Glass Rod | Included in model WJ-162, WJ-164, WJ-424 and WJ- 422 | N/A | N/A | Yes (11 models) No (10 models) | SE Note 2 | | Dimensions | Refer to table 1 | N/A | N/A | N/A | SE Note 3 | | Accessories | N/A | N/A | N/A | High -speed handpieces Wrench, Connector (for inserting lubricant) Low-speed handpieces Head opener for the latch type, Connector for inserting lubricant, External Spray Tubing with nozzle | SE Note 4 | | Compositio n of material | Stainless steel, Brass, Aluminum, Titanium | Stainless steel, Brass. Aluminum, Titanium | Stainless Steel, Brass, Titanium | Stainless steel and titanium | SE | | Chuck | Push button, Screw | Push button, Screw | Push button Latch-type chuck | push button, latch, screw, snap-on or tip- lock chuck options | SE | | Bur extraction force | 28N | 28N | -- | 30N | SE | | Maximum air pressure | Dental High-speed Turbine Handpiece: 200kPa ~ 250kPa (29.01 psi~ 36.25 psi) Dental Low-speed Turbine Handpiece: 245 ~ 392 kPa (35.53 psi~ 56.85 psi) | 177kPa ~ 301kPa (25.67 psi~ 45.66 psi) | 245 ~ 392 kPa (35.53 psi~ 56.85 psi) | 36psi to 43psi | SE Note 3 | | Maximum water pressure | Dental High-speed Turbine Handpiece: 200kPa ~ 250kPa (29.01 psi~ 36.25 psi) Dental Low-speed Turbine Handpiece: 245 ~ 392 kPa (35.53 psi~ 56.85 psi) | | | | | | Speed in rpms | Dental High-speed Turbine Handpiece: 300,000rpm ~ 400,000rpm Dental Low-speed Turbine Handpiece: 18,000 ~ 20,000 rpm | 300,000rpm ~ 400,000rpm | 18,000 ~ 22,000 rpm | High -speed handpieces 320,000 ~ 400,000rpm Low-speed handpieces Up to 20,000 rpm | SE Note 3 | | Conformanc e with standards for shanks | Type 3 per ISO 1797-1 | Type 3 per ISO 1797-1 | Type 3 per ISO 1797-1 | N/A | SE | | Coupling dimensions | Complied with ISO 3964 | N/A | Complied with ISO 3964 | N/A | SE | | Hose connections | Type 1 for 2-hole model / Type 2 for 4- hole model | Type 1 for 2-hole model / Type 2 for 4- hole model | Type 1 for 2- hole model / Type 2 for 4- hole model | N/A | SE | | Lubricant | The specified lubricant, type "PANA SPRAY Plus" manufactured by NAKANISHI INC (cleared in K163483), must be used during routine maintenance. | The specified lubricant, type "PANA SPRAY Plus" manufactured by NAKANISHI INC (cleared in K163483), must be used during routine maintenance. | The specified lubricant, type "PANA SPRAY Plus" manufactured by NAKANISHI INC (cleared in K163483), must be used during routine | Pana-Spray made by NSK(K052700 ) | SE Note 5 | | | | | maintenance. | | | | Compliance Standards | Complied with ISO 10993-5, ISO 10993-10, IEC 60601-1, IEC 80601- 2-60, ISO14457, ISO 17665, ISO 11138, ISO 11607, ISO 17664 | Complied with ISO 10993-5, ISO 10993- 10, ISO14457 | Complied with ISO 10993-5, ISO 10993-10, ISO14457 | Complied with ISO 17665, ISO 11138, ISO 11135, ISO 11607, ISO 17664, and USP 30- NF 25,ISO 14457, ISO 10993-5 | SE Note 6 | # 7. Comparison to predicate device and conclusion {7}------------------------------------------------ {8}------------------------------------------------ {9}------------------------------------------------ ## Comparison in Detail ## Note 1: Although the subject devices are a little difference from predicate devices in "Intended Used", but it's the combination of predicate devices K170229 and K170236. And it's the same with K141886. So, the difference will not raise any substantial equivalence issue. ## Note 2: Although the subject devices are a little difference from predicate devices in "Fiberoptic" glass rod to transmit light, but the subject devices are compliance with safety standard IEC 60601-1 instead. But it's the same with K141886. So the difference will not raise any substantial equivalence issue. ## Note 3: Although the subject devices are a little difference from predicate devices in "Dimensions", "Maximum air pressure", "Maximum water pressure" and "Speed in rpms", the subject devices are it's the features combination of predicate devices K170229 and K170236 and K141886. So, the difference will not raise any substantial equivalence issue. ## Note 4: The subject devices are a little difference from predicate devices in "Accessories" with K141886, but it's the same with the predicate devices K170229 and K170236. The accessories in predicate devices are mainly tools for cleaning handpieces. Not part of predicate devices. So the accessories do not affect the product performance. So, the difference will not raise any substantial equivalence issue. ## Note 5: The subject devices are a little difference from predicate devices in "Lubricant", but the Lubricant is only used for lubrication. As long as it meets the requirements and is FDA cleared, Lubricant can achieve lubrication. Therefore, which brand of Lubricant is used does not affect the performance of the device. So, the difference will not raise any substantial equivalence issue. {10}------------------------------------------------ # Note 6: The common sterilization method of dental handpieces is steam sterilization, because the structure and material characteristics of dental handpieces:. The common dental handpieces sterilization method in the market is also steam sterilization. Therefore, ISO 17665 is applicable standard for verification of steam sterilization. The sterilization method adopted by the subject device is the commonly used steam sterilization. Because the sterilization USES steam, there is no other harmful residue after sterilization. Therefore, there is no need to refer to ISO 11135 and USP 30-NF25 for subject device. So, the difference will not raise any substantial equivalence issue. # Finial conclusion: The subject device Dental High-speed Turbine Handpiece (WJ-114, WJ-124, WJ -122, WJ- 134, WJ -132, WJ -144, WJ -142, WJ -154, WJ -152, WJ -164, WJ -162), Dental Low-speed Turbine Handpiece (WJ-414, WJ-412, WJ-424, WJ-422) has all features of predicate devices. Thus, the subject device is substantially equivalent to the predicate device.