Caries removal, Cavity and crown preparation, Removal of dental restorations (fillings and prostheses), Finishing of teeth and dental restorations (preparation/adjustment).

Device Description

The Titanium Turbine is an air-driven dental handpiece used by qualified dental professionals. The Titanium Turbine is connected to a dental unit via a coupling and uses supplied compressed air to rotate a dental bar attached to its tip at a high speed (380.000-450.000 min-') to enable dental treatment.

Titanium Turbine is mainly made of titanium and can be reused by reprocessing. This device is equipped with a Clean Head System that reduces suck-buck into the head and exhaust line, thereby reducing cross-contamination of the air lines. Titanium Turbine is also equipped with a quick stop system that reduces the time required to stop rotation, thereby improving oral cavity safety, and reducing suck-buck.

AI/ML Overview

The provided text describes the 510(k) premarket notification for a dental handpiece called "Titanium Turbine." It details the device's characteristics, its comparison to predicate devices, and the performance testing conducted to demonstrate substantial equivalence.

However, the information requested regarding acceptance criteria and a study proving the device meets the acceptance criteria (specifically related to AI/algorithm performance and human reader studies) is not present in the provided document. This document pertains to a Class I dental handpiece, which is a mechanical device, not an AI or algorithm-driven medical device. Therefore, the concepts of sensitivity, specificity, MRMC studies, human-in-the-loop performance, and ground truth establishment for AI models are not applicable to the information given.

The document focuses on demonstrating substantial equivalence to predicate dental handpieces based on:

Mechanical and operational characteristics: Head size, weight, head angle, rotation speed, torque, noise level, chuck design, bur type, power, device features (Clean Head System, Quick Stop System).
Material properties: Coating (DURAGRIP vs. Sand blasting finish/Plasmatec coating), direct/indirect patient contacting materials (Titanium vs. Stainless Steel).
Sterilization and lubrication: Methods and compatible products.
Performance testing against established standards: ISO 14457:2017 ("Dentistry Handpieces and motors") and ISO 17665-1:2006 ("Sterilization of health care products - Moist heat").
Biocompatibility testing: According to ISO 10993-1:2018.

Therefore, I cannot populate the requested table and study details as they are outside the scope of this FDA submission for a mechanical dental device.

Summary regarding the absence of requested information:

No AI/Algorithm Component: The device, "Titanium Turbine," is a mechanical dental handpiece. It does not involve any artificial intelligence, machine learning algorithms, or image analysis components.
Acceptance Criteria: The "acceptance criteria" for this device are its compliance with recognized performance standards (ISO 14457, ISO 17665-1) and biocompatibility standards (ISO 10993-1), and demonstrating substantial equivalence to predicate devices based on its physical and functional characteristics. These are not performance metrics like sensitivity/specificity for AI.
Study Proving Acceptance: The "study" proving acceptance is the series of non-clinical performance and biocompatibility tests conducted according to the listed ISO standards. No clinical study was required for this 510(k).
Irrelevant Metrics: All the specific points requested (sample size for test/training sets, data provenance, number of experts for ground truth, adjudication methods, MRMC studies, standalone performance, type of ground truth, training set ground truth establishment) are relevant to the validation of AI/ML-based medical devices, not mechanical devices like a dental handpiece.

Summary

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Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo is in blue and includes the letters "FDA" in a square and the words "U.S. FOOD & DRUG ADMINISTRATION".

June 2, 2023

Nakanishi Inc. Yuki Gomi RA Dept 700 Shimohinata Kanuma, Tochigi 322-8666 Japan

Re: K230888

Trade/Device Name: Titanium Turbine Regulation Number: 21 CFR 872.4200 Regulation Name: Dental Handpiece And Accessories Regulatory Class: Class I, reserved Product Code: EFB Dated: March 31, 2023 Received: April 3, 2023

Dear Yuki Gomi:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part

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801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4. Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely,

Bobak Shirmohammadi -S

For Michael E. Adjodha, M.ChE.,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

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Indications for Use

510(k) Number (if known)

Device Name Titanium Turbine

Indications for Use (Describe)

The Titanium Turbine is intended for the following applications:

Caries removal, Cavity and crown preparation, Removal of dental restorations (fillings and prostheses), Finishing of teeth and dental restorations (preparation/adjustment).

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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Section 5. 510(k) Summary

Date Prepared: December 20, 2022

Submitter

NAKANISHI INC. 700 Shimohinata Kanuma Tochigi 322-8666, Japan TEL: +81-289-64-7277 FAX: +81-289-62-9738 Contact: Masaaki Kikuchi m-kikuchi@nsk-nakanishi.co.jp

Device

Device Name:	Titanium Turbine
Common Name:	Handpiece, Air-Powered, Dental
Regulation Number:	21 CFR 872.4200
Regulation Name:	Dental Handpiece and Accessories
Regulatory Class:	I
Product Codes:	EFB

Predicate Device

Predicate Device Name:	Stainless Turbine
510(k) Number:	K203791
Company Name	NAKANISHI INC.
Reference Device Name:	MASTERTORQUE LUX 8900 L
510(k) Number:	K130560

Device Description

Indications for Use

The Titanium Turbine is intended for the following applications:

Caries removal, Cavity and crown preparation, Removal of dental restorations (fillings and prostheses), Finishing of teeth and dental restorations (preparation/adjustment).

NAKANISHI ING

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Comparison of Technological Characteristics with the Predicate Device

A comparison of the technical characteristics of the subject device and the previous example is shown below.

Characteristics	Subject Device	Predicate Device	Reference Device	Comparison
Device Name	Titanium Turbine	Stainless Turbine	MASTERTORQUE LUX 8900 L
Indications for Use	The Titanium Turbine isintended for the followingapplications:Caries removal, Cavityand crown preparation,Removal of dentalrestorations (fillings andprostheses), Finishing ofteeth and dentalrestorations(preparation/adjustment).	The Stainless Turbine isintended for the followingapplications:Caries removal, Cavityand crown preparation,Removal of dentalrestorations (fillings andprostheses), Finishing ofteeth and dentalrestorations (preparation /adjustment).	The MASTERtorque LUX8900 L is intended for theremoval of cariousmaterial, reducing of hardtooth structure, cavity andcrown preparations,removal of fillings,processing and finishingtooth preparations,restorations, and forpolishing teeth. They aredesigned for use by atrained professional in thefield of general dentistry.	Identical: The subjectdevice and the referencedevice differ only in thedevice name.Similar: The subjectdevice and the referencedevice have similarindications for use.
Principles of Operation	Air from a dental chair,coolant water, coolantchip air, the power forlight will be supplied tothe handpieces viacouplings.	Air from a dental chair,coolant water, coolantchip air, the power forlight will be supplied tothe handpieces viacouplings.	Through the tube and theMULTIflex couplingconnected to a dentalunit, the air-poweredhandpiece receives theair for high speed turbine,the cooling water and airfor cutting treatmentthrough pouring holesand light for illuminationthe operation area.	Identical: The principlesof operation of thesubject device and thepredicate device areidentical.Similar: The principles ofoperation of the subjectdevice and referencedevices are similar.
Power Source	Compressed Air, Lighting	Compressed Air, Lighting	Compressed Air, Lighting	Identical
Characteristics	Subject Device	Predicate Device	Reference Device	Comparison
	powered by Dental Unit	powered by Dental Unit	powered by Dental Unit
Head Size(Diameter xHeight)	$φ$ 9.0 x H 10.8 mm	$φ$ 8.6 x H 9.1 – $φ$ 12.1 x H13.3 mm	$φ$ 12.5 x H 13.0 mm	Difference: There is adifference in the headsize of the subject device.The head size of thesubject device falls withinthe head size range ofthe predicate device,supporting substantialequivalence.
Weight	33 – 39 g	44 – 65 g	Information not available	Difference: There is adifference in the weight ofthe subject device. ISO14457 conformancetesting is performed tosupport substantialequivalence.
Head Angle	100°	90°	100°	Difference: There is adifference in the headangle of the subjectdevice. However, it isidentical to the headangle of the referencedevice and supportssubstantial equivalence.
	powered by Dental Unit	powered by Dental Unit	powered by Dental Unit
Rotation Speed	380,000 - 450,000 min-1	325,000 - 450,000 min-1	340,000 - 400,000 min-1	Similar: The rotationalspeeds of the subjectdevice fall within therange of the predicatedevice, and the maximum
Characteristics	Subject Device	Predicate Device	Reference Device	Comparison
Torque	$\ge 0.05$ cN·m	$\ge 0.05$ cN·m	Information not available	rotational speeds areidentical.
Noise-Level	$\le 80$ dBA	$\le 80$ dBA	Information not available	Identical
Chuck Design	Push Button	Push Button	Push Button	Identical
Bur Type	ISO 1797 Type 3Φ1.59 – 1.60 mm	ISO 1797-1 Type 3Φ1.59 – 1.60 mm	ISO 1797-1 Type 3Φ1.59 – 1.60 mm	Identical: The onlydifference is the versionof the standard.
Power	20 W	9 – 26 W	31 W	Similar: The power fallswithin the range of theprecedent device.
Device Features	Clean Head SystemQuick Stop System	All handpieces:Clean Head SystemS-Max pico BLED, Allcouplings:Anti-Retraction Valve	Direct Stop Technology	Identical: The CleanHead System has thesame functionality as theprecedent device.Difference: The QuickStop System of thesubject device is afeature not found in thepredicate device.However, it is similar tothe Direct StopTechnology of thereference device andsupports substantialequivalence.
Coating	DURAGRIP	Sand blasting finish	Plasmatec coating	Difference: The subjectdevice differs from thepredicate and referencedevices because
Characteristics	Subject Device	Predicate Device	Reference Device	Comparison
				DURAGRIP is used for the coating. Biocompatibility testing confirms compliance with ISO 10993-1 and supports substantial equivalence.
Lubrication	PANA SPRAY Plus (K163483)	PANA SPRAY Plus (K163483)	KaVo QUATTROcare (K071288)	Identical
Sterilization Type	Steam sterilization (Autoclave)	Steam sterilization (Autoclave)	Steam sterilization (Autoclave)	Identical
Direct/Indirect patient Contacting Materials	Stainless Steel, Stainless Steel (CrN coated), Fluororubber, Glass, Titanium (CrN coated), Brass (NiCr plating), Resin	Stainless Steel, Fluororubber, Glass, Brass (Ni plating), Brass (NiCr plating), Resin	Stainless Steel, german silver (nickel – chromium coated), PEEK and Fluoride Rubber Viton	Difference: The subject device differs from the predicate and reference devices because it is made of titanium. Biocompatibility testing confirms compliance with ISO 10993-1 and supports substantial equivalence.

NAKANISHI INC.

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Image /page/7/Picture/0 description: The image shows the logo for NSK, a Japanese manufacturer of bearings. The logo consists of the letters "NSK" in a bold, sans-serif font. A white line extends over the top of the letters. The background is a dark blue color.

NAKANISHI INC.

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Image /page/8/Picture/0 description: The image shows the logo for NSK, a Japanese manufacturer of bearings. The logo consists of the letters "NSK" in a bold, sans-serif font. The letters are white and are set against a dark blue background. The top of the "N" and "K" are connected by a horizontal line.

Performance Testing

The following performance testing were performed to support substantial equivalence.

Non-Clinical Performance Testing:

The Titanium Turbine of the subject device was provided with verification/validation testing to support substantial equivalence. These test results demonstrate compliance with the requirements of the following harmonized standards.

ISO 14457:2017 "Dentistry Handpieces and motors" ●
o ISO 17665-1:2006 "Sterilization of health care products - Moist heat - Part 1: Requirements for the development, validation and routine control of a sterilization process for medical devices"

Biocompatibility:

The Titanium Turbine of the subject device is classified as surface contact device and devices that have limited contact with mucous membranes (less or equal to 24 hours) based on the intended use. For biocompatibility evaluation, the following tests were performed to meet the requirements of ISO 10993-1:2018 "Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process" and the FDA guidance, Use of International Standard ISO 10993-1, "Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk process".

ISO 10993-5 Cytotoxicity Test
ISO 10993-10 Sensitization Test
ISO 10993-10 Irritation Test
ISO 10993-11 Acute Systemic Toxicity Test
ISO 10993-11 Pyrogen Test

Clinical Study:

No clinical study was required to support a determination of the substantial equivalence of the Titanium Turbine.

Conclusion

The performance test results support the substantial equivalence of the subject Titanium Turbine to the precedent device. The differences between the subject device and the precedent device do not raise different issues of safety and effectiveness. The same technical characteristics, including indications, also lead to the conclusion that the Titanium Turbine is substantially equivalent to the precedent device.

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.