(269 days)
No
The device description and performance studies focus on mechanical and electrical functions, safety features (overheating risk reduction), and compliance with standards. There is no mention of AI, ML, image processing, or data-driven decision making.
Yes.
The device is intended for use in dental restoration, prophylaxis, and endodontic procedures, which are therapeutic interventions.
No
The device description indicates it is a motor system used for dental procedures like restoration, prophylaxis, and endodontics, which are treatment-oriented. It drives and regulates the speed of an electric micromotor for performing these procedures. There is no mention of the device being used to identify or analyze a condition, disease, or its risk.
No
The device description explicitly states that the NLZ Motor System consists of hardware components including a Main Unit, Control Unit, Motor, and potentially a Contra Angle Handpiece. The performance studies also include testing of these physical components (biocompatibility, electrical safety, bench testing, reprocessing validation). While there is mention of software verification testing for overheating risk reduction functions, the device is clearly not solely software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states the device is for "dental restoration, prophylaxis and endodontic procedures." These are procedures performed directly on the patient's teeth and surrounding tissues.
- Device Description: The description details a motor system and handpieces used to drive dental tools. This is consistent with a device used for physical manipulation during dental procedures.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens derived from the human body (like blood, urine, tissue, etc.) to provide information for diagnosis, monitoring, or screening.
IVD devices are specifically designed to perform tests on biological samples outside of the body. This device is used within the body during dental treatment.
N/A
Intended Use / Indications for Use
The NLZ Motor System is intended for use by dental professionals in the performance of dental restoration, prophylaxis and endodontic procedures.
The NLZ Endo is intended for use by dental professionals in the performance of dental endodontic procedures.
Product codes (comma separated list FDA assigned to the subject device)
EBW
Device Description
NLZ Motor Systems are available in two models;
NLZ Motor Set, which consists of the Main Unit, the Control Unit and the Motor.
NLZ E Motor Set, which consists of the Main Unit, the Control Unit, the Motor, and the Contra Angle Handpiece: NLZ Endo. The NLZ Endo is available only for NLZ E Motor Set and is not avialable for the NLZ Motor Set. The NLZ Endo is not equipped with any cooling system because it is a speed-reducing/low-speed handpiece.
The Control Unit drives an electric micromotor, and turns on off or regulates the speed of an electric motor by its foot pedal of the dental unit. This product can be connected to dental units currently in use to add on a brushless electric micromotor with an LED light.
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
dental professionals
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
Performance testing including biocompatibility testing, Electric safety and EMC testing, bench testing was performed in order to demonstrate substantial equivalence to the predicates. Also, reprocessing validation was performed because both the Motor and the NLZ Endo are required cleaning and sterilization after use by user. Cleaning, sterilization, and drying time recommended in the instruction were validated using AAMI TIR 12:2010, AAMI TIR 30:2011, and FDA Reprocessing guidance. The NLZ Motor System met all requirements of the standards. Because the NLZ Motor System is equipped with the overheating risk reduction functions with which the E-STATIS 40 Electric Motor System (K090937) is not equipped, those functions are compared with the functions of the ELECTROtorque TLC 4893 (K103027). The Contra-SAFE function of the subject device has similar features to the SAFEdrive function of the ELECTROtorque TLC 4893 (K103027). The ELECTROtorque TLC 4893 (K103027) does not equipped the functions such as the Contra-Check and Contra-Restriction of the subject device. The performance testing for the Contra-Check and Contra-Restriction does not raise any new concern. Therefore, the NLZ Motor system demonstrated substantial equivalence to the predicates.
Biocompatibility test was performed using the Motor and the NLZ Endo: Cytotoxicity in accordance with ANSI/AAMI/ISO 10993-5:2009, Sensitization in accordance with ISO 10993-10:2010, Irritation in accordance with ISO 10993-10:2010. No biocompatibility concern was raised.
Bench tests were performed in order to verify conformity to ISO 14457:2012. All samples were compliant with ISO 14457:2012.
Electromagnetic compatibility testing in accordance with IEC 60601-1-2:2014 and electrical safety testing in accordance with AAMI / ANSI/ES60601-1:2005/(R)2012 and A1:2012,, C1:2009/(R)2012 and A2:2010/(R)2012 were performed. Those test results indicate that the NLZ Motor System does not raise concern.
Performance testing for the overheating risk reductions was performed in accordance with in-house standard. This testing is verification test for software by putting excessive load to the Motor in order to confirm proper Contra-Check judge and motor speed control for Contra-Restriction and Contra-SAFE. The test results indicate that those safety functions do not raise any new concern. In addition, we analyzed temperature increase for returned handpieces due to overheating/burn event and confirmed that the overheating/burn event should be reduced by the overheating risk reduction features.
No animal or clinical testing was performed.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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.
0
Image /page/0/Picture/1 description: The image is a black and white logo for the Department of Health & Human Services - USA. The logo consists of a circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the top half of the circle. Inside the circle is a stylized symbol that resembles three human profiles facing to the right, stacked on top of each other, with flowing lines beneath them.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
August 31, 2017
Nakanishi Inc. % Izumi Maruo Senior Consultant MIC International Corp. 4-1-17 Hongo Bunkyo-ku, Tokyo 1130033 JAPAN
Re: K163402
Trade/Device Name: NLZ Motor System Regulation Number: 21 CFR 872.4200 Regulation Name: Dental Handpiece and Accessories Regulatory Class: Class I Product Code: EBW Dated: July 21, 2017 Received: August 1, 2017
Dear Izumi Maruo:
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. 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
1
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 (reporting of medical devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely,
Andrew I. Steen -S
for Lori A. Wiggins, MPT, CLT Acting Director Division of Anesthesiology, General Hospital, Respiratory, Infection Control, and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K163402
Device Name NLZ Motor System
Indications for Use (Describe)
The NLZ Motor System is intended for use by dental professionals in the performance of dental restoration, prophylaxis and endodontic procedures.
The NLZ Endo is intended for use by dental professionals in the performance of dental endodontic procedures.
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)
PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.
FOR FDA USE ONLY
Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)
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3
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K163402
510(k) Summary
- a. Owner/Company name, address NAKANISHI INC. 700 Shimohinata, Kanuma-shi, Tochigi, 322-8666, Japan
b. Contact
Kimihiko Satoh General Manager, Regulatory Affairs Department NAKANISHI INC. 700 Shimohinata, Kanuma-shi, Tochigi, 322-8666, Japan
| Phone: | +81-289-64-4325 |
|---|---|
| Fax: | +81-289-62-6665 |
| Email: | k-satoh@nsk-nakanishi.co.jp |
c. Application Correspondent
Izumi Maruo Senior Consultant MIC International 4-1-17 Hongo, Bunkyo-ku Tokyo, 113-0033, Japan
| Phone: | +81-3-3818-8577 |
|---|---|
| Fax: | +81-3-3818-8573 |
| Email: | maruo@mici.co.jp |
d. Date prepared
July 21, 2017
e. Name of device
Trade Name: Classification Name: Regulation Name: Regulatory Class: Product Code:
NLZ Motor System Controller, Foot, Handpiece and Cord Dental handpiece and accessories Class I EBW
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f. Predicate devices and reference device
| Predicate device | |
|---|---|
| 510(k): | K090937 |
| Trade name: | E-STATIS 40 Electric Motor System |
| Company name: | SciCAN |
| Product code: | EBW |
The E-STATIS 40 Electric Motor System (K090937) does not include a handpiece. Therefore, the predicate device for the contra-angle handpiece, NLZ Endo is shown below.
| Predicate device for the NLZ Endo | |
|---|---|
| 510(k): | K150750 |
| Trade name: | Contra-Angle Handpiece :Endo 6:1 |
| Company name: | Sirona Dental Systems GmbH |
| Product code: | EGS |
This submission uses following reference device for the reciprocating mode of the NLZ Motor System. The E-STATIS 40 Electric Motor System (K090937) is not equipped with that mode.
| Reference Device | |
|---|---|
| 510(k): | K103653 |
| Trade name: | e3TM Torque Control Motor |
| Company name: | DENTSPLY International Inc. |
| Product code: | EBW |
| 510(k): | K103027 |
| Trade name: | ELECTROtorque TLC 4893 with INTRAmatic KL 702 |
| Company name: | Kaltenbach & Voigt GmbH |
| Product code: | EBW, EKX |
g. Description of the device
NLZ Motor Systems are available in two models;
NLZ Motor Set, which consists of the Main Unit, the Control Unit and the Motor.
NLZ E Motor Set, which consists of the Main Unit, the Control Unit, the Motor, and the Contra Angle Handpiece: NLZ Endo. The NLZ Endo is available only for NLZ E Motor Set and is not avialable for the NLZ Motor Set. The NLZ Endo is not equipped with any cooling system because it is a speed-reducing/low-speed handpiece.
The Control Unit drives an electric micromotor, and turns on off or regulates the speed of an electric motor by its foot pedal of the dental unit. This product can be connected to dental
5
units currently in use to add on a brushless electric micromotor with an LED light.
h. Indications for Use
The NLZ Motor System is intended for use by dental professionals in the performance of dental restoration, prophylaxis and endodontic procedures.
The NLZ Endo is intended for use by dental professionals in the performance of dental endodontic procedures.
Statement of substantial equivalence i.
The Indications for Use of the NLZ Motor System is identical to the E-STATIS 40 Electric Motor System (K090937).
The NLZ Motor System and the E-STATIS 40 Electric Motor System (K090937) have the similar functions and characteristics regarding the range of rotating speed, rotation direction, and auto reverse/auto stop.
The NLZ Motor System is equipped with similar reciprocating mode to the reference device.
Following table is comparison between the subject, the predicate and the reference devices.
6
| Subject Device | Predicate Device | Reference Device | Reference Device | |
|---|---|---|---|---|
| NLZ Motor System | E-STATIS 40 Electric | |||
| Motor System (K090937) | ELECTROtorque TLC | |||
| 4893 (K103027) | e3TM Torque Control Motor | |||
| (K103653) | ||||
| Indications | ||||
| for | ||||
| Use | The NLZ Motor System is | The E-STATIS type 40 | The ELECTROtorgue TLC | The e3 Torque Control Motor |
| intended for use by dental | dental system is intended | 4893 is intended to convert | is a medical device designed | |
| professionals | ||||
| in | ||||
| the | for use by dental | pneumatic output from a | for use by dentists for use | |
| performance | ||||
| of | ||||
| dental | professionals in the | dental treatment center to | with dental root canal | |
| restoration, | ||||
| prophylaxis | performance of dental | electrical energy to drive | instruments in continuous | |
| and | ||||
| endodontic | restoration, prophylaxis and | the INTRAmatic KL 702 | rotation with torque control or | |
| procedures. | endodontic procedures. | motor for operation of | in reciprocating movement. | |
| electrically driven | ||||
| [Indications for Use for | dental handpieces. These | |||
| NLZ Endo] | devices are designed for | |||
| The NLZ Endo is intended | use by a trained | |||
| for use | ||||
| by dental | professional in the field of | |||
| professionals | ||||
| in the | general dentistry. | |||
| performance | ||||
| of | ||||
| endodontic procedures. | ||||
| Drive | Electronic-micromotor | Electronic-micromotor | Electronic-micromotor | Electronic-micromotor |
| Components | Power supply, Motor | |||
| controller, Electric | ||||
| micromotor, and | Power supply, Motor | |||
| controller, and Electric | Power supply, Motor | |||
| controller, and Electric | Power supply, Motor | |||
| controller, Foot pedal, Electric | ||||
| micromotor and Contra-angle | ||||
| Contra-angle handpiece | micromotor | micromotor | handpiece (K972436) | |
| (NLZ Endo, NLZ E Motor | ||||
| Set ONLY) | ||||
| Light | LED | Light bulb | LED | No light |
| - Light intensity | >10,000[lx] | Unknown | Unknown | NA |
Table 1. Comparison table for outline of the motor system
7
| Range of rotation speed (rpm) | 100 - 40,000 rpm | 100 - 40,000 rpm | 100 - 40,000 rpm | 250 - 1,000 rpm |
|---|---|---|---|---|
| Rotating direction | Forward and Reverse | Forward and Reverse | Forward and Reverse | Forward and Reverse |
| Standard operation mode | Yes | Yes | Yes | No |
| -Overheating risk reduction features | Yes* | No | Yes* | NA |
| Reciprocating mode | Yes (NLZ E Motor Set ONLY) | No | No | Yes |
| -Intended file | WaveOne | NA | NA | Wave One |
| -6:1 gear ratio handpiece designed for rotary and reciprocating modes is provided with the Motor | Yes | NA | NA | Yes |
| - Preset parameters for the reciprocating mode | Yes (User cannot alter the parameters) | NA | NA | Yes (User cannot alter the parameters) |
| Rotary Endo Mode | Yes (NLZ E Motor Set ONLY) | Yes | Yes | Yes |
| - Auto reverse/Auto Stop function | Yes | Yes | Yes | Yes |
| Motor | ||||
| overheating | ||||
| prevention | ||||
| function | Yes | Unknown | Yes | Unknown |
| Maximum air/water pressure | ||||
| -Coolant air | ||||
| supply | 0.40 MPa | 0.40 MPa | 0.5 MPa | No coolant circuit |
| -Spray water | ||||
| supply | 0.25 MPa | 0.25 MPa | 0.25 MPa | No spray circuit |
| -Spray air | ||||
| supply | 0.25 MPa | 0.20 MPa | 0.20 MPa | No spray circuit |
| Sterilization | Sterilized by user | |||
| (steam sterilization) | Sterilized by user | |||
| (steam sterilization) | Sterilized by user | |||
| (steam sterilization) | The contra-angle handpiece | |||
| only is sterilized by user | ||||
| Available | ||||
| Handpiece type | E-type (ISO3964) | E-type (ISO3964) | ISO3964 conformed | |
| attachment | E-type (ISO3964) |
8
- For detail comparison regarding overheating risk reduction features, please see Table 2.
9
Based on Table 1, the NLZ E Motor Set provides "Reciprocating Endo Mode" and "Rotary Endo Mode" in addition to standard operation mode (in the NLZ Motor System, named "General Application Mode"). The Reciprocating Endo Mode of the NLZ E Motor Set is designed for use with WaveOne file designed for unequal counterclockwise (150°) and clockwise (30°) rotation. In order to perform reciprocating endo treatment safely, we provide the NLZ Endo handpiece which was verified for use with the WaveOne and presetting parameters of this treatment for the NLZ Endo with the WaveOne on the NLZ E Motor Set. User cannot alter those presetting parameters. The reciprocating mode of the reference device, e3 M Torque Control Motor (K103653) has identical features to the Reciprocating Endo Mode, which means;
Both modes are designed for use with WaveOne file 1.
-
Both modes provide automatic unequal counterclockwise (150°) and clockwise (30°) rotation
-
Both modes provide a 6:1 handpiece which was verified for use with the WaveOne and presetting parameters for using the providing handpiece combined with the WaveOne file. 4. User cannot alter the presetting parameters
The Rotary Endo Mode of the NLZ E Motor Set provides the continuous one direction rotation for use with low-speed handpieces and three modes when the set torque reached. The values of rotation speed and torque can be adjusted. The features for "Endodontic Mode" of the E-STATIS 40 Electric Motor System (K090937) are identical to those for this mode.
Regarding standard operation mode, the provided rotation direction and range of rotation speed of the subject device are identical to those of the E-STATIS 40 Electric Motor System (K090937). Although the NLZ Motor System is equipped with the overheating risk reduction functions in order to reduce patient burns caused by overheated handpiece, the predicate device E-STATIS 40 Electric Motor System (K090937) is not equipped with such function. Therefore, such functions of the subject device are compared with a reference device, ELECTROtorque TLC 4893 (K103027).
10
| Table 2. Comparison of overheating risk reduction functions | |||
|---|---|---|---|
| Overheating | |||
| risk | |||
| reduction | |||
| function | NLZ Motor System (K163402/S001) | ELECTROtorque | |
| 4893 (K103027) | TLC | ||
| Detection of | |||
| defective | |||
| handpieces | Contra-SAFE | SAFEdrive | |
| - Detection | |||
| of | |||
| overheating | Indirectly by measuring load for the | ||
| handpiece and the duration of time | Indirectly by continuous | ||
| monitoring of the idling | |||
| properties of the | |||
| handpiece during its use. | |||
| - Features | This function automatically stops motor | ||
| rotation or controls the speed when higher | |||
| and continued load of motor current are | |||
| detected. | If the protective function | ||
| is triggered, the | |||
| SAFEdrive initially | |||
| reduces the motor speed | |||
| and then stops the motor | |||
| altogether if the excessive | |||
| load persists | |||
| Judge and | |||
| display of | |||
| the | |||
| handpiece | |||
| status | Contra-Check | The device does not have | |
| this function | |||
| - Features | 1) A manual feature for indirect detection | ||
| of excessive friction by measuring current | |||
| consumption of the Motor |
- Providing the status of handpiece
regarding potential overheating as follows;
● OK: The check result is acceptable
● OIL: Needs a maintenance such as
lubricating with oil
● NG: There is a serious
malfunction
● NG blinking: Damaged handpiece | NA | |
| Motor speed
control
function after
Contra-
Check | Contra-Restriction | NA | |
| -Features | This function restricts motor rotation when
handpiece is used for judge other than OK
through estimating temperature increase by
the Control Unit. The motor is slowed
down and stopped after speed control. | NA | |
Table 2. Comparison of overheating risk reduction functions
11
| ● If NG blinking is displayed, the | |
|---|---|
| motor is stopped and cannot be | |
| activated. | |
| If NG is displayed, the motor is | |
| stopped approximately 10 seconds | |
| after continuous use. | |
| If Oil is displayed, the motor is | |
| stopped approximately 20 seconds | |
| after continuous use. |
In addition, the subject device and the ELECTROtorque TLC 4893 (K103027) are equipped with the Motor overheat prevention function. The motor overheat prevention function indirectly detects overheat of the Motor itself in order to protect the Motor from failure of the coils. The purpose of design for this function is different from handpiece overheating risk reduction features described above.
This function of the subject device estimates temperature increase of the Motor by the motor current and rotation speed. The ELECTROtorque TLC 4893 (K103027) detects overload.
Regarding the handpiece, the comparison table is shown below;
| | NLZ Endo | Contra-Angle
Handpiece :Endo 6:1 (K150750 ) |
|------------------------------|-----------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------|
| Design features | Contra-Angle, Push-Button
Chuck, Motor coupling, Without
light and cooling system | Contra-Angle, Push-Button
Chuck, Motor coupling, Without
light and cooling system |
| Gear ratio | 6:1 Reduction | 6:1 Reduction |
| Maximum motor/drive
speed | 6,000 rpm | 40,000 rpm |
| Materials | Stainless Steel | Stainless Steel |
| Motor coupling | Compliant with ISO 3964 | Compliant with ISO 3964 |
| Source of power | Electronic-micromotor
NLZ E Motor Set Only | Electronic-micromotor |
| Dimension | Head Diameter: 8.6mm
Head Height: 11.3mm
Length: 81.9mm | Head Diameter: 8.7mm
Head Height: 11.4mm
Length: 92.3mm |
| Weight | 66 g | 70 g |
| Performance | Compliant with ISO 14457 | Compliant with ISO 14457 |
| -Eccentricity | 0.018 mm | Unknown |
| -Force for bur extraction | >45N | Unknown |
| Sterilization | Sterilized by user
(steam sterilization) | Sterilized by user
(steam sterilization) |
| Lubricant | PANA SPRAY Plus
(510(k) number is K131014) | Sirona T1 spray
(510(k)number is K113674) |
Table 3. Comparison table for the Contra-angle handpiece
12
| Bur | Contra-angle burs
ISO1797-1 Type1 | Contra-angle burs
ISO1797-1 Type1 |
|---------------------|--------------------------------------|--------------------------------------|
| -Maximum bur length | 46 mm | 25 mm |
Both the NLZ Endo and the Contra-Angle Handpiece :Endo 6:1 (K150750) are used for dental endodontic procedures. The main design features and gear ratio of the NLZ Endo are similar to those of the Contra-Angle Handpiece : Endo 6:1 (K150750). Although there are some differences between the NLZ Endo and the Contra-Angle Handpiece :Endo 6:1 (K150750), the performance characteristics of both devices are compliant with ISO 14457.
For the NLZ Motor System, performance testing including biocompatibility testing, Electric safety and EMC testing, bench testing was performed in order to demonstrate substantial equivalence to the predicates. Also, reprocessing validation was performed because both the Motor and the NLZ Endo are required cleaning and sterilization after use by user. Cleaning, sterilization, and drying time recommended in the instruction were validated using AAMI TIR 12:2010, AAMI TIR 30:2011, and FDA Reprocessing guidance. The NLZ Motor System met all requirements of the standards. Because the NLZ Motor System is equipped with the overheating risk reduction functions with which the E-STATIS 40 Electric Motor System (K090937) is not equipped, those functions are compared with the functions of the ELECTROtorque TLC 4893 (K103027). The Contra-SAFE function of the subject device has similar features to the SAFEdrive function of the ELECTROtorque TLC 4893 (K103027). The ELECTROtorque TLC 4893 (K103027) does not equipped the functions such as the Contra-Check and Contra-Restriction of the subject device. The performance testing for the Contra-Check and Contra-Restriction does not raise any new concern. Therefore, the NLZ Motor system demonstrated substantial equivalence to the predicates.
Biocompatibility j.
Following biocompatibility test was performed using the Motor and the NLZ Endo:
- Cytotoxicity in accordance with ANSI/AAMI/ISO 10993-5:2009
- Sensitization in accordance with ISO 10993-10:2010
- Irritation in accordance with ISO 10993-10:2010
In the biocompatibility testing reports, no biocompatibility concern was raised.
k. Bench Testing
The bench tests were performed in order to verify conformity to ISO 14457:2012.
All samples were compliant with ISO 14457:2012.
Also, electromagnetic compatibility testing in accordance with IEC 60601-1-2:2014 and electrical safety testing in accordance with AAMI / ANSI/ES60601-1:2005/(R)2012 and A1:2012,, C1:2009/(R)2012 and A2:2010/(R)2012 were performed. Those test results indicate that the NLZ Motor System does not raise concern.
13
Performance testing for the overheating risk reductions was performed in accordance with in-house standard. This testing is verification test for software by putting excessive load to the Motor in order to confirm proper Contra-Check judge and motor speed control for Contra-Restriction and Contra-SAFE. The test results indicate that those safety functions do not raise any new concern. In addition, we analyzed temperature increase for returned handpieces due to overheating/burn event and confirmed that the overheating/burn event should be reduced by the overheating risk reduction features.
No animal or clinical testing was performed.
l. Conclusion
The indications for use of the NLZ Motor System is identical to the E-STATIS 40 Electric Motor System (K090937). Although there are some differences in characteristics between the NLZ Motor System and the predicates, a number of performance testing indicated that the NLZ Motor System met the requirement of the standards. Based on above result, we conclude the NLZ Motor System is substantially equivalent to the predicates and does not raise any new safety and effectiveness concern.