What is the FDA product code for Dental Handpiece (Model: J6-126, J6-136, SH11W2, SH11W3, W401LW, W15LW, W142LW, W11L)?

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

What is the regulatory pathway for Dental Handpiece (Model: J6-126, J6-136, SH11W2, SH11W3, W401LW, W15LW, W142LW, W11L)?

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

What are the predicate devices for Dental Handpiece (Model: J6-126, J6-136, SH11W2, SH11W3, W401LW, W15LW, W142LW, W11L)?

General Cutting Contra Handpiece (K182999).

Who can help prepare an FDA 510(k) submission like Dental Handpiece (Model: J6-126, J6-136, SH11W2, SH11W3, W401LW, W15LW, W142LW, W11L)?

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.

Dental Handpiece (Model: J6-126, J6-136, SH11W2, SH11W3, W401LW, W15LW, W142LW, W11L)

Q: Who is the manufacturer of Dental Handpiece (Model: J6-126, J6-136, SH11W2, SH11W3, W401LW, W15LW, W142LW, W11L)?

Guangdong Jinme Medical Technology Co., Ltd. filed the 510(k) submission for Dental Handpiece (Model: J6-126, J6-136, SH11W2, SH11W3, W401LW, W15LW, W142LW, W11L) (K240337).

K240337 · Guangdong Jinme Medical Technology Co., Ltd. · EFB · Nov 13, 2024 · Dental

Device Facts

Record ID	K240337
Device Name	Dental Handpiece (Model: J6-126, J6-136, SH11W2, SH11W3, W401LW, W15LW, W142LW, W11L)
Applicant	Guangdong Jinme Medical Technology Co., Ltd.
Product Code	EFB · Dental
Decision Date	Nov 13, 2024
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 872.4200
Device Class	Class 1
Attributes	Therapeutic

Intended Use

For Model J6-126, J6-136: The Dental 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. For Model SH11W2, SH11W3, W401LW, W15LW, W142LW, W11L: The Dental Handpiece 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.

Device Story

Dental handpieces (models J6-126, J6-136, SH11W2, SH11W3, W401LW, W15LW, W142LW, W11L) designed for clinical dental use; powered by air or electric motors. Components include head, handle, transmission shaft, and cartridge. Connects to standard ISO 3964 couplings or ISO 9168 hose connectors; accepts ISO 1797-1 compliant instruments. Provides mechanical cutting, grinding, and polishing capabilities for tooth and restorative materials. Some models include LED or fiberoptic illumination. Operated by dentists/dental professionals in clinical settings. Non-sterile; requires steam sterilization (moist heat) before first use and between patients. Output is mechanical rotation of dental burs/instruments to facilitate dental procedures; aids in efficient removal of tooth structure and restorative materials.

Clinical Evidence

No clinical data included. Substantial equivalence supported by bench testing, including electrical safety (IEC 60601-1, IEC 80601-2-60), electromagnetic compatibility (IEC 60601-1-2), biocompatibility (ISO 10993-1, -5, -10, -23), and performance testing per ISO 14457. Reprocessing validation performed per ISO 17665-1.

Technological Characteristics

Materials: Stainless steel, brass, titanium, aluminum. Energy: Air-powered or electric-powered. Connectivity: ISO 3964 coupling, ISO 9168 connector. Interface: ISO 1797-1 shank. Illumination: LED or fiberoptic (≥7000 lx). Sterilization: Steam autoclave (moist heat) per ISO 17665-1. Performance: ISO 14457 compliant.

Indications for Use

Indicated for dental professionals performing procedures including removal of carious material, cavity/crown preparation, finishing/trimming of teeth and restorations, root canal preparation, polishing, and removal of crowns/filling materials.

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

General Cutting Contra Handpiece (K182999)

Reference Devices

Dental High-speed Turbine Handpiece (K170229)
Surgical Angle Handpiece, Surgical Straight Handpiece (K171155)

Related Devices

K220577 — Dental Handpiece, Model CA160, CA160L, and CA500L · Micro-Nx Co., Ltd. · Jul 29, 2022
K093971 — DENTAL HANDPIECE · North West Medical Instrument (Group) Co., Ltd. · Apr 22, 2010
K182999 — General Cutting Contra Handpiece · Nakanishi, Inc. · Apr 16, 2019
K102517 — TIGER 500 SERIES HIGH SPEED HANDPIECES AND ATTACHMENTS · Thunder Tiger Corp. · Apr 27, 2011
K192809 — Dental Handpiece · Micro-Nx Co., Ltd. · Aug 25, 2020

Submission Summary (Full Text)

{0}------------------------------------------------ Image /page/0/Picture/0 description: The image contains 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. November 13, 2024 Guangdong JINME Medical Technology Co., Ltd. % Cassie Lee Manager Guangzhou GLOMED Biological Technology Co., Ltd. 2231, Building 1, Rui Feng Center, Kaichuang Road, Huangpu District, Guangzhou Guangdong. CHINA Re: K240337 Trade/Device Name: Dental Handpiece (Model: J6-126. J6-136. SH11W2. SH11W3. W401LW. W15LW. W142LW. W11L) Regulation Number: 21 CFR 872.4200 Regulation Name: Dental Handpiece And Accessories Regulatory Class: Class I. reserved Product Code: EFB, EGS Dated: October 8, 2024 Received: October 15, 2024 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 (the 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 available 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. {1}------------------------------------------------ Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510/k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download). Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30, Design controls; 21 CFR 820.90, Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181). 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 of medical device-related adverse events) (21 CFR Part 803) for devices or postmarketing safety reporting (21 CFR Part 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 Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050. All medical devices, including Class I and unclassified devices and combination product device constituent parts are required to be in compliance with the final Unique Device Identification System rule ("UDI Rule"). The UDI Rule requires, among other things, that a device bear a unique device identifier (UDI) on its label and package (21 CFR 801.20(a)) unless an exception or alternative applies (21 CFR 801.20(b)) and that the dates on the device label be formatted in accordance with 21 CFR 801.18. The UDI Rule (21 CFR 830.300(a) and 830.320(b)) also requires that certain information be submitted to the Global Unique Device Identification Database (GUDID) (21 CFR Part 830 Subpart E). For additional information on these requirements, please see the UDI System webpage at https://www.fda.gov/medical-device-advicecomprehensive-regulatory-assistance/unique-device-identification-system. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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 {2}------------------------------------------------ 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 -S Michael E. Adjodha, MChE, RAC, CQIA 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 {3}------------------------------------------------ # Indications for Use Submission Number (if known) K240337 Device Name Dental Handpiece (Model: J6-126, J6-136, SH11W2, SH11W3, W401LW, W15LW, W142LW, W11L) Indications for Use (Describe) For Model J6-126, J6-136: The Dental 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. For Model SH11W2, SH11W3, W401LW, W15LW, W142LW, W11L: The Dental Handpiece 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) > Prescription Use (Part 21 CFR 801 Subpart D) 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." {4}------------------------------------------------ # 510(k) Summary of K240337 This 510(k) summary is being submitted in accordance with the requirement of 21 CFR 807.92. #### 1. Date of the summary prepared: 2024-11-13 # 2. Submitter's Information Company Name: Guangdong JINME Medical Technology Co., Ltd. Address: Room 301, 401, 501, Block No.3, Wanyang Science Park, 84 Taoyuan East Rd. Shishan Town, Nanhai District, Foshan, Guangdong, CHINA Contact name: Yinq Yanq Title: Manager Tel: +86-13929914992 Fax: / E-mail: 1109607962@qq.com # Application Correspondent Contact Person: Ms. Cassie Lee Company: Guangzhou GLOMED Biological Technology Co., Ltd. Address: 2231, Building 1, Rui Feng Center, Kaichuang Road, Huangpu District, Guangzhou, Guangdong, China Title: Manager Tel: +86 2082662446 Email: regulatory@glomed-info.com #### 3. Subject Device Information Company Name: Guangdong JINME Medical Technology Co., Ltd. Trade/Device Name: Dental Handpiece (Model: J6-126, J6-136, SH11W2, SH11W3, W401LW, W15LW, W142LW, W11L) Common Name: Handpiece, Contra- And Right-Angle Attachment, Dental (EGS), Handpiece, Air-Powered Dental (EFB) Classification Name: Dental handpiece and accessories Primary Product Code: EFB Secondary Product Code: EGS Regulation Number: 21 CFR 872.4200 Review Panel: Dental Regulatory Class: I #### 4. Predicate Device Information Predicate Device: 510(k) Number: K182999 Company Name: Nakanishi Inc. Trade/Device Name: General Cutting Contra Handpiece {5}------------------------------------------------ Common Name: Handpiece, Contra- And Right-Angle Attachment, Dental Classification Name: Dental Handpiece And Accessories Product Code: EGS Regulation Number: 21 CFR 872.4200 Requlatory Class: I # Reference Device 1: 510(k) Number: K170229 Company Name: Guangdong JINME Medical Technology Co., Ltd. Trade/Device Name: Dental High-speed Turbine Handpiece Model: T, S, TU, SU, TP, SP, TUQ, TUP, SUP, SUQ, TUQP, SUQP Common Name: Handpiece, Air-Powered, Dental Classification Name: Dental Handpiece And Accessories Product Code: EFB Requlation Number: 21 CFR 872.4200 Regulatory Class: I #### Reference Device 2: 510(k) Number: K171155 Company Name: NAKANISHI INC. Trade/Device Name: Surgical Angle Handpiece, Surgical Straight Handpiece Common Name: Handpiece, Rotary Bone Cutting Classification Name: Dental Handpiece And Accessories Product Code: KMW, EGS Regulation Number: 21 CFR 872.4200 Regulatory Class: I #### 5. Device Description The Dental Handpiece is mainly composed of a machine head, handle, transmission shaft, and cartridge, and is designed to be attached to the drive via standard coupling which complies with ISO 3964 and hose connector which complies with ISO 9168. The head clamp accepts an instrument complying with ISO 1797-1. The handpieces are intended to be powered by air-powered or electric-powered, and they are also intended to provide optic series. They are intended to be provided non-sterile, so they must be sterilized prior to first use and sterilized after each subsequent use using steam sterilization (moist heat sterilization). #### 6. Indications for Use For Model J6-126, J6-136: The Dental 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. #### For Model SH11W2, SH11W3, W401LW, W15LW, W142LW, W11L: The Dental Handpiece 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. {6}------------------------------------------------ # 7. Comparison to predicate devices Compared with the predicate devices, the subject device is very similar in technical design, intended use/indications for use, functions, etc. And the differences between the subject device and predicate devices do not raise new questions of safety or effectiveness. Please refer to the detailed Substantial Equivalence Comparison of the subject device and predicate devices in the following table. | Elements of Comparison | Subject Device | Predicate Device (K182999) | Reference Device 1 (K170229) | Reference Device 2 (K171155) | Remark | |-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------| | Company | Guangdong JINME Medical Technology Co., Ltd. | Nakanishi Inc. | Guangdong JINME Medical Technology Co., Ltd. | NAKANISHI INC. | -- | | Device Name | Dental Handpiece | General Cutting Contra Handpiece | Dental High- speed Turbine Handpiece | Surgical Straight/Angle Handpiece | -- | | 510(k) Number | K240337 | K182999 | K170229 | K171155 | -- | | Regulation Number | 21 CFR 872.4200 | 21 CFR 872.4200 | 21 CFR 872.4200 | 21 CFR 872.4200 | Same | | Product Code | EFB, EGS | EGS | EFB | KMW, EGS | Same | | Class | | | | | Same | | Intended Use / Indications for Use | For Model J6- 126, J6-136: The Dental 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. For Model SH11W2, SH11W3, W401LW, | 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 | 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. | The Surgical Straight/Angle Handpiece Series is intended for use by licensed professionals for oral surgical and dental use. Typical uses include sectioning and removal of wisdom teeth, cutting teeth, oral surgery (such as root tip resection, bone removal, bone shaping) and implant treatment (such | Same as Predicate device and Reference device 1 | | Elements of Comparison | Subject Device | Predicate Device (K182999) | Reference Device 1 (K170229) | Reference Device 2 (K171155) | Remark | | W142LW, W11L: The Dental Handpiece 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. | materials and removal of crowns and filling materials. | | maxilla and mandible). | | | | Device Design | | | | | | | Operational Modes | Electronical- powered or Air- powered | Electronical- powered or Air- powered | Air-powered | Electronical- powered or Air- powered | Same as predicate device | | Water Spray | Yes | Yes | Yes | Yes | Same | | Fiberoptics | For model J6- 136, J6-126: No, LED For model W15LW, W142LW, W11L, W401LW: Yes, Fiberoptics For SH11W2, SH11W3: No | Optic and non- optic | / | Non-optic | Similar Note 1 | | Dimensions | J6-126: $φ12.5*136$ J6-136: $φ12.5*101$ SH11W2: $φ19.7*101$ SH11W3: | No publicly available | T: $φ12.5*133$ S: $φ11.2*125$ TU: $φ12.5*125.7$ SU: $φ11.2*124.5$ TP: $φ12.5*126$ SP: $φ11.2*134$ TUQ: $φ12.5*127$ | Overall length varies between 108.7mm〜135m m | Different Note 2 | | Elements of Comparison | Subject Device | Predicate Device (K182999) | Reference Device 1 (K170229) | Reference Device 2 (K171155) | Remark | | | $φ$ 19.3*133 W401LW: $φ$ 13.68*97.7 W15LW: $φ$ 9.5*96 W142LW: $φ$ 9.5*88 W11LW: $φ$ 9.9*97.8 | | TUP: $φ$ 12.5*135 SUP: $φ$ 11.2*131 SUQ: $φ$ 11.2*127 TUQP: $φ$ 12.5*127 SUQP: $φ$ 11.2*127 | | | | Type of Chunk | Gland chuck, Mechanical chuck | No publicly available | Push button, Screw | Gland chuck (Bur Lock Ring Chuck) | Different Note 3 | | Coupling and connector dimensions | For model J6- 136, J6-126: ISO 9168 Type 3 For model SH11W2, SH11W3, W401LW, W15LW, W142LW, W11L: ISO 3964 Standard Coupling | ISO 3964 Standard Coupling | ISO 9168 Type 1, Type 2, Type 3 | ISO 3964 Standard Coupling | Same | | Accessories | Wrench, Oil Injection Quick coupling | No publicly available | / | No publicly available | Different Note 4 | | Composition of Main Materials | 1) Head of handpiece (Stainless Steel, Brass, Titanium) 2) Back cover of Head (Stainless steel) 3) Water path (Stainless steel) 4) Air path (Stainless | No publicly available | Stainless Steel, Brass, Titanium | Stainless Steel, Aluminum | Same with reference device 2 | | Elements of Comparison | Subject Device | Predicate Device (K182999) | Reference Device 1 (K170229) | Reference Device 2 (K171155) | Remark | | | steel) | | | | | | Technical Specifications | | | | | | | Light intensity | ≥7000 lx | No publicly available | ≥7000 lx | No publicly available | Same with reference device 2 | | Bur Extraction Force | For model J6- 126, J6-136, W15LW, W142LW: ≥22N For model SH11W2, SH11W3, W401LW, W11L: ≥45N | No publicly available | 28N | No publicly available | Similar Note 5 | | Maximum air pressure | For model J6- 126, J6-136, W11L only: 300kPa | No publicly available | 177KPa ~ 301KPa | No publicly available | Similar Note 6 | | Maximum water pressure | For model W401LW, W142LW, W15LW, W11L, J6-126, J6-136 only: 200kPa | No publicly available | For Model T, TU, TP, TUQ, TUP, TUQP: 0.3 MPa; For Model S, SU, SP, SUP, SUQ, SUQP: 0.25 MPa; | No publicly available | Similar Note 7 | | Rotation Speed | For model J6- 126, J6-136: 300,000rpm ~ 340,000rpm For model SH11W2, SH11W3, W401LW, W15LW, W142LW, W11L: Max Rotation Speed of compatible motors: max. 40,000 rpm | Max. 40,000 rpm | 300,000rpm ~ 400,000rpm | Max Rotation Speed of compatible motors: max. 40,000 rpm | Similar Note 8 | | Elements of Comparison | Subject Device | Predicate Device (K182999) | Reference Device 1 (K170229) | Reference Device 2 (K171155) | Remark | | | 40,000 rpm | | | | | | Gear Ratio Max rotation speed | For model J6- 126, J6-136: Not applicable For model SH11W2, SH11W3, W401LW, W15LW, W142LW, W11L: 1:1 Direct Drive 1:4.2 Increasing 1:5 Increasing 40:1 Reduction | 1:1 Direct Drive 1:5 Increasing 16:1 Reduction 10:1 Reduction 4:1 Reduction | Not applicable | 1:1 Direct Drive 1:2 Increasing | Similar Note 9 | | Shank | ISO 1797-1 (Type 1) ISO 1797-1 (Type 2) ISO 1797-1 (Type 3) | ISO 1797-1 (Type 1) ISO 1797-1 (Type 3) | ISO 1797-1 (Type 3) | ISO 1797-1 (Type 2) | Similar Note 10 | | Lubricants | NSK PANA SPRAY Plus (K163483) | NSK PANA SPRAY Plus (K163483) | NSK PANA SPRAY Plus (K163483) | No publicly available | Same | | Sterilization Method | Steam Autoclave (Moist Heat) | Steam Autoclave (Moist Heat) | Steam Autoclave (Moist Heat) | Steam Autoclave (Moist Heat) | Same | | Sterilization Standard | ISO 17665-1 | ANSI/AAMI/ISO 17665-1 | ISO 17665-1 | ISO 17665-1 | Same | | Performance and Safety | ISO 14457 | ISO 14457 | ISO 14457 | ISO 14457 | Same | | Biocompatibility Safety | ISO 10993-1 ISO 10993-5 ISO 10993-10 ISO 10993-23 | ISO 10993-1 ISO 10993-5 ISO 10993-10 | ISO 10993-1 ISO 10993-5 ISO 10993-10 | ISO 10993-1 ISO 10993-5 ISO 10993-10 | Same | {7}------------------------------------------------ {8}------------------------------------------------ {9}------------------------------------------------ {10}------------------------------------------------ # Comparison in Detail(s): Note 1: Although there are differences in fiberoptics, the handpiece with the light have been tested according to ISO 14457 performance requirements. The test results demonstrate that the illuminance of the handpiece light meets ISO 14457 standard's requirements. So, this difference between the subject {11}------------------------------------------------ and predicate devices does not raise new safety and effectiveness questions. Note 2: Although the "Head Dimensions" of the subject device is different from the predicate devices, the dimensions are similar to predicate devices. Safety and performance tests were conducted according to IEC 60601 series standards, ISO 14457, ISO 17665, and ISO 10993 series standards, the results demonstrate that the subject device complies with the ISO standards' requirements. So, the difference between the subject and predicate devices does not raise new safety and effectiveness questions. Note 3: Although the "Type of Chuck" of the subject device is different from the predicate devices, the extraction force of the bur chucked should be designed with the ISO 14457 requirements and the extraction force of the bur of the subject device has been tested according to ISO 14457, the results demonstrate that the subject device complies with the standards' requirements. So, the difference between the subject and predicate devices does not raise new safety and effectiveness questions. Note 4: Although the "Accessories" of the subject device is different from the predicate devices because the information on accessories of predicate devices is not published. The accessories provided with the subject device include a wrench for assembling and an Oil Injection Quick coupling for maintenance which are common accessories for dental handpieces. These accessories will not affect the product's safety and performance, so, the difference between the subject and predicate devices does not raise new safety and effectiveness questions. Note 5: Although the "Bur Extraction Force" of the subject device is slightly different from the predicate devices, both the force of the subject device and the predicate devices confirm with ISO 14457 requirements, and the "Bur Extraction Force" of the subject device has been tested according to ISO 14457, the results demonstrate that the subject device is in compliance with the standards' requirements. So, the difference between the subject and predicate devices does not raise new safety and effectiveness questions. Note 6: Although the "Maximum air pressure" of the subject device is slightly different from the predicate devices, the "Maximum air pressure" of the subject device similar to the reference device K170229 and can be fully covered by the predicate device K170229. The maximum air pressure conforms with ISO 14457 requirements, the results of the subject device demonstrate that the subject device is in compliance with the standards' requirements. So, the difference between the subject and predicate devices does not raise new safety and effectiveness questions. Note 7: Although the "Maximum water pressure" of the subject device is slightly different from the predicate devices because the Max. water pressure information of predicate devices is not published. The "Maximum water pressure" of our subject device is very common water pressure recommended by legally marketed devices. The Maximum water pressure confirms with ISO 14457 requirements. So, the difference between the subject and predicate devices does not raise new safety and effectiveness questions. N…