(282 days)
No
The summary describes a mechanical dental handpiece with standard components and power sources. There is no mention of AI, ML, image processing, or data analysis that would indicate the use of such technologies. The performance studies focus on electrical safety, EMC, biocompatibility, and mechanical performance, not algorithmic validation.
Yes
The device is a dental handpiece intended for various dental procedures such as removing carious material, cutting and grinding teeth, and preparing cavities, which are considered therapeutic interventions.
No
The intended use of the dental handpiece is for removing, cutting, grinding, and preparing dental materials and teeth, which are therapeutic and restorative actions, not diagnostic ones.
No
The device description explicitly details physical components like a machine head, handle, transmission shaft, and cartridge, and mentions being attached to a drive and accepting instruments, indicating it is a hardware device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly describes the device's function as a tool for mechanical procedures on teeth (removing material, preparing cavities, finishing, polishing, cutting, grinding). This is a direct intervention on the patient's body.
- Device Description: The description details a mechanical handpiece with components like a machine head, handle, transmission shaft, and cartridge, designed to be attached to a drive. This aligns with a surgical/dental tool, not a device used to examine specimens from the body.
- Lack of IVD Characteristics: There is no mention of the device being used to test or examine specimens (blood, tissue, etc.) outside of the body to provide information for diagnosis, monitoring, or treatment.
IVD devices are specifically designed to perform tests on samples taken from the human body. This dental handpiece is a tool used directly on the patient's teeth.
N/A
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, 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.
Product codes
EFB, EGS
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).
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies
Non-clinical tests were performed on the subject device in order to validate the design and to assure conformance with the following standards and FDA Guidance document:
- Electrical safety test according to IEC 60601-1, IEC 80601-2-60 and IEC 62417 standard;
- Electromagnetic compatibility test according to IEC 60601-1-2 and IEC/TR 60061-4-2 standard;
- FDA Guidance document, Reprocessing Medical Devices in Health Care Settings: Validation Methods and Labeling;
- FDA Guidance document, Dental Handpieces - Premarket Notification [510(k)] Submissions
- Biocompatibility safety test according to ISO 10993-1, ISO 10993-5, ISO 10993-10 and ISO 10993-23;
- Performance test according to ISO 14457;
- Validation of the effectiveness of reprocessing and validation of the maximum number of reprocessing cycles according to ISO 17665-1;
Clinical testing was not included in the submission.
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 872.4200 Dental handpiece and accessories.
(a)
Identification. A dental handpiece and accessories is an AC-powered, water-powered, air-powered, or belt-driven, hand-held device that may include a foot controller for regulation of speed and direction of rotation or a contra-angle attachment for difficult to reach areas intended to prepare dental cavities for restorations, such as fillings, and for cleaning teeth.(b)
Classification. Class I.
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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)
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)
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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:
$φ12.5136$
J6-136:
$φ12.5101$
SH11W2:
$φ19.7101$
SH11W3: | No publicly
available | T: $φ12.5133$
S: $φ11.2125$
TU: $φ12.5125.7$
SU: $φ11.2124.5$
TP: $φ12.5126$
SP: $φ11.2134$
TUQ: $φ12.5127$ | 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 |
| | $φ$ 19.3133
W401LW:
$φ$ 13.6897.7
W15LW: $φ$ 9.596
W142LW:
$φ$ 9.588
W11LW:
$φ$ 9.997.8 | | TUP: $φ$ 12.5135
SUP: $φ$ 11.2131
SUQ: $φ$ 11.2127
TUQP:
$φ$ 12.5127
SUQP:
$φ$ 11.2127 | | |
| 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.
Note 8: The Rotation Speed of the handpiece J6-1126 is close to the predicate device K170299, and the speed of J6-1126 and J6-136 can be fully covered by the reference device K170229.
12
Besides, the recommended motor speed for the other models except J6-126 and J6-136 is the same as the predicate device K182999. The Rotation Speed of the subject device confirms with ISO 14457 requirements, so the difference between the subject and predicate devices does not raise new safety and effectiveness questions
Note 9: Although the "Gear Ration speed (handpiece)" of the subject device is slightly different from the predicate device K182999, the "Gear Ration speed (handpiece)" of the subject device is very similar to the predicate device, and both of them have the same recommended motor speed. Besides, there is also a wide range of gear ratios for this kind of device, such as the reference device K171436, which has a wider Gear Ratio of 20:1, 16:1, 32:1, and 1:1. Furthermore, the max. rotation speed (handpiece) of the subject device confirms with ISO 14457, so the difference between the subject and predicate devices does not raise new safety and effectiveness questions
Note 10: The "Shank" type design of the subject device are the predicate device and reference device, and all of them are designed in common use type according to ISO 1797-1 requirements. The bur extraction force also should be tested according to ISO 14457, the results demonstrated that the extraction force for all kinds of the shank applicable can meet the ISO 14457 standards' requirements, so the difference between the subject and predicate devices does not raise new safety and effectiveness questions.
8. Test Summary
8.1 Summary of Non-clinical tests
Non-clinical tests were performed on the subject device in order to validate the design and to assure conformance with the following standards and FDA Guidance document:
- Electrical safety test according to IEC 60601-1, IEC 80601-2-60 and IEC 62417 standard; -
- -Electromagnetic compatibility test according to IEC 60601-1-2 and IEC/TR 60061-4-2 standard;
- । FDA Guidance document, Reprocessing Medical Devices in Health Care Settings: Validation Methods and Labeling;
- -FDA Guidance document, Dental Handpieces - Premarket Notification [510(k)] Submissions
- -Biocompatibility safety test according to ISO 10993-1, ISO 10993-5, ISO 10993-10 and ISO 10993-23;
- -Performance test according to ISO 14457;
- -Validation of the effectiveness of reprocessing and validation of the maximum number of reprocessing cycles according to ISO 17665-1;
8.2 Summary of Clinical Testing
Clinical testing was not included in the submission..
9. Final conclusion
The conclusions drawn from the nonclinical tests demonstrate that the subject device is as safe, as effective, and performs as well as or better than the predicate devices.