(63 days)
No
The device description and performance studies focus on mechanical and material properties, sterilization, and biocompatibility, with no mention of AI/ML algorithms or data processing.
Yes
The device is used for medical applications such as caries removal, cavity preparation, and removal of dental restorations, which are therapeutic interventions.
No
The device description and intended use clearly state that the Titanium Turbine is a dental handpiece used for therapeutic procedures like caries removal, cavity preparation, and removal of dental restorations. It is not described as providing any diagnostic information or assessment.
No
The device description clearly states it is an air-driven dental handpiece made mainly of titanium, indicating it is a physical hardware device.
Based on the provided information, the Titanium Turbine is not an In Vitro Diagnostic (IVD) device.
Here's why:
- IVD Definition: In Vitro Diagnostics are devices intended for use in the examination of specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This examination is performed outside of the body (in vitro).
- Titanium Turbine Function: The description clearly states the Titanium Turbine is an air-driven dental handpiece used for procedures performed directly on the patient's teeth and oral cavity. Its functions include caries removal, cavity preparation, removal of restorations, and finishing. These are all in vivo procedures.
- Lack of Specimen Analysis: There is no mention of the device being used to analyze any biological specimens (like blood, urine, tissue, etc.) for diagnostic purposes.
Therefore, the Titanium Turbine is a dental surgical/procedural device, not an IVD.
N/A
Intended Use / 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).
Product codes
EFB
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.
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
qualified 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)
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"
- 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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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.
0
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
1
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
2
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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3
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
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.
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
4
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 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). | The Stainless 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). | The MASTERtorque LUX | |||
| 8900 L is intended for the | ||||
| removal of carious | ||||
| material, reducing of hard | ||||
| tooth structure, cavity and | ||||
| crown preparations, | ||||
| removal of fillings, | ||||
| processing and finishing | ||||
| tooth preparations, | ||||
| restorations, and for | ||||
| polishing teeth. They are | ||||
| designed for use by a | ||||
| trained professional in the | ||||
| field of general dentistry. | Identical: The subject | |||
| device and the reference | ||||
| device differ only in the | ||||
| device name. | ||||
| Similar: The subject | ||||
| device and the reference | ||||
| device have similar | ||||
| indications for use. | ||||
| Principles of Operation | Air from a dental chair, | |||
| coolant water, coolant | ||||
| chip air, the power for | ||||
| light will be supplied to | ||||
| the handpieces via | ||||
| couplings. | Air from a dental chair, | |||
| coolant water, coolant | ||||
| chip air, the power for | ||||
| light will be supplied to | ||||
| the handpieces via | ||||
| couplings. | Through the tube and the | |||
| MULTIflex coupling | ||||
| connected to a dental | ||||
| unit, the air-powered | ||||
| handpiece receives the | ||||
| air for high speed turbine, | ||||
| the cooling water and air | ||||
| for cutting treatment | ||||
| through pouring holes | ||||
| and light for illumination | ||||
| the operation area. | Identical: The principles | |||
| of operation of the | ||||
| subject device and the | ||||
| predicate device are | ||||
| identical. | ||||
| Similar: The principles of | ||||
| operation of the subject | ||||
| device and reference | ||||
| devices 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 x | ||||
| Height) | $φ$ 9.0 x H 10.8 mm | $φ$ 8.6 x H 9.1 – $φ$ 12.1 x H | ||
| 13.3 mm | $φ$ 12.5 x H 13.0 mm | Difference: There is a | ||
| difference in the head | ||||
| size of the subject device. | ||||
| The head size of the | ||||
| subject device falls within | ||||
| the head size range of | ||||
| the predicate device, | ||||
| supporting substantial | ||||
| equivalence. | ||||
| Weight | 33 – 39 g | 44 – 65 g | Information not available | Difference: There is a |
| difference in the weight of | ||||
| the subject device. ISO | ||||
| 14457 conformance | ||||
| testing is performed to | ||||
| support substantial | ||||
| equivalence. | ||||
| Head Angle | 100° | 90° | 100° | Difference: There is a |
| difference in the head | ||||
| angle of the subject | ||||
| device. However, it is | ||||
| identical to the head | ||||
| angle of the reference | ||||
| device and supports | ||||
| substantial 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 rotational |
| speeds of the subject | ||||
| device fall within the | ||||
| range of the predicate | ||||
| device, 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 are |
| identical. | ||||
| 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 3 | |||
| Φ1.59 – 1.60 mm | ISO 1797-1 Type 3 | |||
| Φ1.59 – 1.60 mm | ISO 1797-1 Type 3 | |||
| Φ1.59 – 1.60 mm | Identical: The only | |||
| difference is the version | ||||
| of the standard. | ||||
| Power | 20 W | 9 – 26 W | 31 W | Similar: The power falls |
| within the range of the | ||||
| precedent device. | ||||
| Device Features | Clean Head System | |||
| Quick Stop System | All handpieces: | |||
| Clean Head System | ||||
| S-Max pico BLED, All | ||||
| couplings: | ||||
| Anti-Retraction Valve | Direct Stop Technology | Identical: The Clean | ||
| Head System has the | ||||
| same functionality as the | ||||
| precedent device. | ||||
| Difference: The Quick | ||||
| Stop System of the | ||||
| subject device is a | ||||
| feature not found in the | ||||
| predicate device. | ||||
| However, it is similar to | ||||
| the Direct Stop | ||||
| Technology of the | ||||
| reference device and | ||||
| supports substantial | ||||
| equivalence. | ||||
| Coating | DURAGRIP | Sand blasting finish | Plasmatec coating | Difference: The subject |
| device differs from the | ||||
| predicate and reference | ||||
| devices 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.
5
6
7
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.
8
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.