Predicate Devices

Reference Devices

AI/ML (Artificial Intelligence / Machine Learning)

No
The device description and performance studies focus on mechanical and sterilization properties, with no mention of AI/ML terms or functionalities.

Therapeutic

Yes
The device is used for applications like tooth restoration and root canal preparation, which are therapeutic interventions.

Diagnostic

No

This device, an air motor, is described as converting compressed air into rotary motion to drive handpieces for procedures like tooth restoration, prophylaxis, and root canal preparation. These are therapeutic or preparatory actions, not diagnostic ones. There is no mention of it collecting, analyzing, or interpreting data for the purpose of diagnosis.

SaMD (Software as a Medical Device)

No

The device description explicitly states it is an "air motor" that converts compressed air into rotary motion, which is a hardware component. The performance studies also focus on hardware-related standards like ISO 14457 (performance) and sterilization/cleaning, further indicating it is not software-only.

IVD (In Vitro Diagnostic)

Based on the provided information, this device is not an IVD (In Vitro Diagnostic).

Here's why:

Intended Use: The intended use is for driving handpieces for tooth restoration, prophylaxis, and root canal preparation. These are all procedures performed directly on the patient's teeth.
Device Description: The device description explains how the air motor converts compressed air into rotary motion to power instruments used in dental procedures. This is a mechanical function, not a diagnostic one.
Lack of Diagnostic Function: There is no mention of the device being used to analyze samples (like blood, urine, or tissue) or to provide information about a patient's health status based on such analysis.
Anatomical Site: The anatomical site is the tooth, which is where the physical procedures are performed.
Performance Studies: The performance studies focus on mechanical performance (ISO 14457), sterilization, cleaning, and biocompatibility, which are relevant to a medical device used in direct patient contact, not an IVD.

IVD devices are used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This air motor does not fit that description.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

Air Motor is intended for the following application(s): Driving the handpiece for the tooth restoration, prophylaxis, and root canal preparation.

Product codes (comma separated list FDA assigned to the subject device)

EFB

Device Description

The air motor converts the compressed air supplied from the dental unit into rotary motion. The rotation is transmitted to instruments for tooth restoration, prophylaxis, and root canal preparation connected to straight and geared angle handpieces.

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

tooth

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 (study type, sample size, AUC, MRMC, standalone performance, key results)

Performance: ISO 14457:2017
Sterilization: AAMI/ANSI/ISO 17665-1:2006
Cleaning: Guidance for the Reprocessing Medical Devices in Health Care Settings: Validation Methods and Labeling Guidance for Industry and Food and Drug Administration Staff.
Biocompatibility: ISO 7405: 2018 AAMI/ANSI/ISO 10993-1: 2018
Clinical Testing: NO

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.

K143704

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.

K162926

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

Regulation Number and Section

§ 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.

Summary

0

Image /page/0/Picture/0 description: The image contains the logos of the Department of Health and Human Services and the Food and Drug Administration (FDA). The Department of Health and Human Services logo is on the left, and the FDA logo is on the right. The FDA logo includes the letters "FDA" in a blue square, followed by the words "U.S. Food & Drug Administration" in blue text.

April 25, 2024

NAKANISHI INC. % Takahiro Haruyama President Globizz Corpration 1411 W. 190th St. Suite 200 Gardena, California 90248

Re: K233308

Trade/Device Name: Air Motor (Model name: FX204 M4); Air Motor (Model name: M205) Regulation Number: 21 CFR 872.4200 Regulation Name: Dental Handpiece And Accessories Regulatory Class: Class I, reserved Product Code: EFB Dated: March 7, 2024 Received: March 13, 2024

Dear Takahiro Haruyama:

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 (QS) 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.

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 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).

2

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

Form Approved: OMB No. 0910-0120 Expiration Date: 06/30/2023 See PRA Statement below.

Submission Number (if known)

K233308

Device Name

Air Motor (Model name: FX204 M4) Air Motor (Model name: M205 )

Indications for Use (Describe)

Air Motor is intended for the following application(s): Driving the handpiece for the tooth restoration, prophylaxis, and root canal preparation.

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:

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510(k)#: K233308

510(k) Summary

Contact Details

Applicant Name: NAKANISHI INC. Applicant Address: 700 Shimohinata Kanuma Tochigi, 322-8666, Japan Applicant Contact Telephone: +81-289-64-7277 Applicant Contact: Masaaki Kikuchi Applicant Contact Email: nskra@nsk-nakanishi.co.jp

Device Name

Device Trade Name: Air Motor (Model name: FX204 M4) Air Motor (Model name: M205) Common Name: Dental handpiece and accessories Classification Name: Handpiece, Air-Powered, Dental Regulation Number: 872.4200

Device Class: I Product Codes: EFB

Legally Marketed Predicate Devices

Predicate Device #: K143704 Predicate Trade Name: Advanced Air System Product Code: EFB Reference Device #: K162926 Predicate Trade Name: W&H Air-Powered Handpieces And Handpiece Attachments Product Code: EFB

Device Description Summary

The air motor converts the compressed air supplied from the dental unit into rotary motion. The rotation is transmitted to instruments for tooth restoration, prophylaxis, and root canal preparation connected to straight and geared angle handpieces.

Intended Use/ Indications for Use

Air Motor is intended for the following application(s): Driving the handpiece for the tooth restoration, prophylaxis, and root canal preparation.

NAKANISHI INC.

5

Comparison of Technological Characteristics with the Predicate Device-1

DEVICE AND PREDICATE COMPARISON TABLE-1

For Air Motor, FX204 M4 (model without spray)

Descriptive Information	Subject Device	Primary Predicate Device	Reference Device	Judgement
Device Name	Air Motor, FX204 M4	Advanced Air System
(RM-25 L RM)	Air-Powered Handpieces
and Handpiece
Attachments
(AM-25 RM: model w/o
spray)
K number	K233308	K143704	K162926
Indication for Use	Air Motor is intended for
the following
application(s): Driving the
handpiece for the tooth
restoration, prophylaxis,
and root canal
preparation.	Pneumatic drive system
for dental handpieces and
dental air motors, which is
intended to be used in
general dental applications
such as: removal of
decayed materials, cavities
and crown preparations,
removal of filings, finishing
of tooth and restoration
surfaces, polishing,
prophylaxis and
endodontics	The turbine handpiece is
intended for the following
applications: Removal of
decayed materials, cavities
and crown preparation,
removal of fillings,
finishing of tooth and
restoration surfaces.
The dental
handpiece/contra-angle is
intended for the following
applications: Removal of
decayed materials, cavities
and crown cement,
removal of fillings,
finishing and polishing of
tooth and restoration
surfaces.	Same: all devices are
intended for general
dental applications
including restoration,
dental cleaning
(prophylaxis), and root
canal preparation
Device Description	The air motor converts
the compressed air
supplied from the dental	The Advanced Air System
is intended for dental
transmission instruments	The Air-powered
Handpieces contain pipes
inside which supply air for	Same: all devices use air
motors, are
pneumatically driven

unit into rotary motion. The rotation is transmitted to instruments for tooth restoration, prophylaxis, and root canal preparation connected to straight and geared angle handpieces.	used in the field of preventive dentistry, restorative dentistry such as cavity preparation and prosthodontics such as crown preparation and endodontics. The system consists of the control unit (AC-1.0), which is designed to be built in a dental chair. As an attachment the air-driven handpiece (RK-97 L, RG- 97 L, and/or RK-94 L) or the air motor (RM-25 L RM) can be used. The air-driven handpiece is equipped with a speed sensor, which is connected to a control module that regulates the applied air pressure to the handpiece through a proportional valve in order to maintain constant speed throughout the dental treatment	driving the turbine's impeller as well as supply air and water for creating spray exhausting through 3, 4 or 5 ports located in the handpiece's head and intended for cooling the working area as well as the rotating bur. Depending on the type of handpiece – the handle might contain an integrated circuit board and wire bundles, for supplying current and voltage to a head sided assembled LED light source. The Handpiece Attachments also contain pipes inside which supply air and water for spray exhausting and for cooling the working area as well as the rotating bur. Depending on the type of handpiece – the handle might contain an integrated circuit board and wire bundles, for supplying current and voltage to a head-sided assembled LED light source.	and used for driving dental handpieces.
Supply air	0.20 – 0.25 MPa	0.52 – 0.59 MPa	unknown	Different
The subject device has
				lower pressure
Optic lighting	no	yes	no	Same with Air-Powered
Handpieces and
Handpiece Attachments
Speed range	$19,800 - 24,200 min^{-1}$
(0.25MPa)	$2,000 – 20,000 rpm$	$25,000 +/-10%$	Similar
All devices have similar
upper speed range
Max. air consumption	Similar
Biocompatibility testing
confirms compliance
with ISO 10993-1 and
supports substantial
equivalence.
Relevant testing to
predicate devices.
• Biological safety
evaluation report
• Confirmation of
effectiveness and
biological safety of
accessories
			addition, Cytotoxicity
Testing per EN
ISO 10993-5:2009 was
performed. This evaluation
meets the requirements of
ISO 7405:2008 for
preclinical evaluation of
biocompatibility of dental
devices.	• MSDS
Clinical Testing	NO	NO	NO	Same
Air/water port	No spray	No spray	No Spray	Same
Dimensions	78.3 x φ20 mm	87,87 x φ20 mm	Unknown	Similar dimensions with
Advanced Air System.
ISO 14457 performance
testing supports
substantial equivalence.
Patient-contacting portions	Direct contact: No
Indirect contact: No	Direct contact: Unknown
Indirect contact: No	Direct contact: Unknown
Indirect contact: No	Similar
Conformity to ISO
10993-1 supports
substantial equivalence.
Handpiece Connection	ISO 3964	Unknown	ISO 3964	Same with Air-Powered
Handpieces and
Handpiece
Attachments.
Hose Connection	ISO 9168	Unknown	ISO 9168	Same with Air-Powered
Handpieces and
Handpiece
Attachments.
Lubricant	PANA SPRAY Plus
(K163483)	Unknown	W&H Service Oil F1, MD-
400
W&H Assistina	Similar with Air-
Powered Handpieces
and Handpiece
Attachments.
Conformity to ISO
10993-1 supports
substantial equivalence.

6

7

8

NSK

9

10

Discussion:

Intended use: same. The intended use for the Air Motor FX204 M4 and its predicate device Advanced Air System RM-25 U RM is for general dental applications.

The principle of the operating technology: same (pneumatically driven).

There are differences in the two devices features, such as "supply air pressure". To verify if the subject device affects its efficiency, we compared the subject device and the reference device under air supply pressures, reflecting the and reference device. The performance gap at the lower air supply pressure limit was relatively small. Despite this, the product's performance as an air motor remains sufficient for power transmission to attachments and grinding teeth (Test Report_Equivalence Check of Similar Devices). In terms of performance, it is equivalent to the reference device.

Therefore, we conclude that the subject device Air Motor FX204 M4 and its predicate devices Advanced Air System RM-25 L RM and Air-Powered Handpieces and Handpiece Attachments AM-25 RM are substantially equivalent.

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DEVICE AND PREDICATE COMPARISON TABLE-2

For Air Motor, M205 (Internal Spray equipped)

Descriptive Information	Subject Device	Primary Predicate Device	Reference Device	Judgement
Device Name	Air Motor, M205	Advanced Air System
(RM-25 L RM)	Air-Powered Handpieces
and Handpiece
Attachments
(AM-25 A RM, model with
spray)
K number	K233308	K143704	K162926
Indication for Use	Air Motor is intended for
the following
application(s): Driving the
handpiece for the tooth
restoration, prophylaxis,
and root canal
preparation.	Pneumatic drive system
for dental handpieces and
dental air motors, which is
intended to be used in
general dental applications
such as: removal of
decayed materials, cavities
and crown preparations,
removal of filings, finishing
of tooth and restoration
surfaces, polishing,
prophylaxis and
endodontics	The turbine handpiece is
intended for the following
applications: Removal of
decayed materials, cavities
and crown preparation,
removal of fillings,
finishing of tooth and
restoration surfaces.
The dental
handpiece/contra-angle is
intended for the following
applications: Removal of
decayed materials, cavities
and crown cement,
removal of fillings,
finishing and polishing of
tooth and restoration
surfaces.	Similar: all devices are
intended for general
dental applications
including restoration,
dental cleaning
(prophylaxis), and root
canal preparation
Device Description	The air motor converts
the compressed air
supplied from the dental
unit into rotary motion.
The rotation is	The Advanced Air System
is intended for dental
transmission instruments
used in the field of
preventive dentistry.	The Air-powered
Handpieces contain pipes
inside which supply air for
driving the turbine's
impeller as well as supply	Same: all devices use air
motors, are
pneumatically driven,
and used for driving
dental handpieces.

	transmitted to
instruments for tooth
restoration, prophylaxis,
and root canal
preparation connected to
straight and geared angle
handpieces.
M205 has a water
injection mechanism.	restorative dentistry such
as cavity preparation and
prosthodontics such as
crown preparation and
endodontics.
The system consists of the
control unit (AC-1.0),
which is designed to be
built in a dental chair.
As an attachment the air-
driven handpiece (RK-97 L,
RG- 97 L, and/or RK-94 L)
or the air motor (RM-25 L
RM) can be used.
The air-driven handpiece is
equipped with a speed
sensor, which is connected
to a control module that
regulates the applied air
pressure to the handpiece
through a proportional
valve in order to maintain
constant speed
throughout the dental
treatment	air and water for creating
spray exhausting through
3, 4 or 5 ports located in
the handpiece's head and
intended for cooling the
working area as well as the
rotating bur. Depending on
the type of handpiece –
the handle might contain
an integrated circuit board
and wire bundles, for
supplying current and
voltage to a head sided
assembled LED light
source.
The Handpiece
Attachments also contain
pipes inside which supply
air and water for spray
exhausting and for cooling
the working area as well as
the rotating bur.
Depending on the type of
handpiece – the handle
might contain an
integrated circuit board
and wire bundles, for
supplying current and
voltage to a head-sided
assembled LED light
source.	The subject device, "Air
Motor M205" has the
same technology as
"Air-Powered
Handpieces and
Handpiece
Attachments, model
AM-25 A RM" as both
are equipped with pipes
inside that supply air
and water.
Supply air	0.20 – 0.25 MPa	0.52 – 0.59 MPa
(75 – 85 psi)	unknown	Different
The subject device has
lower pressure
Optic lighting	no	yes	no	Same with Air-Powered
Speed range	19,800 - 24,200 min-1
(0.25MPa)	2,000 – 20,000 rpm	25,000 +/-10%	Handpieces and
Handpiece Attachments
Similar
All devices have similar
Max. air consumption	50(ml/min)	Not relevant	> 50(ml/min)	Same
Water pressure	1 – 2.5 (bar)	Not relevant	1.5-2.5 (bar)	Similar range
Chip air pressure	1.5 – 2.5 (bar)	Not relevant	2-3 (bar)	Similar range
Performance Testing	Performance: ISO
14457:2017
Sterilization:
AAMI/ANSI/ISO 17665-
1:2006
Cleaning: Guidance for
the Reprocessing	Electrical Safety Tests: IEC
60601-1:2005
Electromagnetic
Compatibility: IEC 60601-
1-1:2007
Product testing of
handpiece function and	Product testing of the
handpieces function and
life cycle testing: ISO
14457:2012
EMC Testing: IEC 60601-1-
2:200
Thermal safety: IEC
62471:2006	Similar
All the devices passed
the ISO 14457
Performance testing
Relevant testing to
predicate devices.
• ISO 14457 2017
	Medical Devices in Health
Care Settings: Validation
Methods and Labeling
Guidance for Industry and
Food and Drug
Administration Staff.	life cycle testing: ISO
14457:2012
Software validation: IEC
62304:2006
Usability validation: IEC
62366:2007
Thermal safety: IEC
62471:2006	62471:2006	Conformity
confirmation report
• Drop test report
• Reprocessing
resistance test report
• Water leakage and
water ingress test
report

				• Statistical calculation
of sample size
				• Equivalence
confirmation for
package test report
				• Vibration test report
				• Check valve effect
verification test report
				• Sterilization
validation report
				• Conformity
assessment to the
product family group for
sterilization
				• Product family group
conformity confirmation
on cleaning validation
				• Cleaning validation
report
				• Cleaning validation of
accessories
Biocompatibility	ISO 7405: 2018
AAMI/ANSI/ISO 10993-1:
2018	ISO 7405:2008
ISO 10993-5:2009	ISO 7405:2008
ISO 10993-5:2009
Evaluation of
biocompatibility is based
upon the fact that patient
contacting materials in the
subject handpiece are
identical to those in the
previously cleared
predicates
(K143704 and K070663)	Similar
Biocompatibility testing
confirms compliance
with ISO 10993-1 and
supports substantial
equivalence.

12

13

14

NSK

15

NSK

16

Discussion:

Intended use: same. The intended use for the subject device Air Motor M205 and its predicate device Advanced Air System RM-25 L RM is for general dental applications.

The principle of the operating technology: same (pneumatically driven).

There are differences in the two devices features, such as "supply air pressure". To verify if the subject device affects its efficiency, we compared the subject device and the reference device under air supply pressures, reflecting the range for the subject device and reference device. The performance gap at the lower air supply pressure limit was relatively small. Despite this, the product's performance as an air motor remains sufficient for power transmission to attachments and grinding teeth (Test Report Equivalence Check of Similar Devices). In terms of performance, it is equivalent to the reference device.

Therefore, we conclude that the subject device Air Motor M205 and its predicate Air System RM-25 L RM and Air-Powered Handpieces and Handpiece Attachments AM-25 A RM are substantially equivalent.