Who is the manufacturer of Stainless Turbine?

Nakanishi, Inc. filed the 510(k) submission for Stainless Turbine (K203791).

What is the FDA product code for Stainless Turbine?

EFB. It is classified under 21 CFR 872.4200 as a Class 1 device in the Dental panel.

What is the regulatory pathway for Stainless Turbine?

510(k) clearance (submission type: Traditional).

What are the predicate devices for Stainless Turbine?

T1 / T2 / T3 Turbine family with serial no. > 600,000 (K131319); Ti-Max X450 (K112024).

Who can help prepare an FDA 510(k) submission like Stainless Turbine?

Innolitics — a medical-device software consultancy — provides regulatory and engineering support for FDA 510(k) submissions. See https://innolitics.com/services/510ks/ or contact https://innolitics.com/contact.

Stainless Turbine

K203791 · Nakanishi, Inc. · EFB · Jun 21, 2022 · Dental

Device Facts

Record ID	K203791
Device Name	Stainless Turbine
Applicant	Nakanishi, Inc.
Product Code	EFB · Dental
Decision Date	Jun 21, 2022
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 872.4200
Device Class	Class 1
Attributes	Therapeutic

Intended Use

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 coupling is intended for the following applications: A connection device to transfer energy (air, water, light) required for handpieces.

Device Story

Air-powered high-speed dental handpieces; rotational speeds 325,000–450,000 RPM. Input: compressed air/water/light from dental unit. Operation: air-driven turbine rotates friction grip bur (ISO 1797-1) for cutting/finishing tooth structure. Features: Clean Head System (CHS) to reduce foreign matter ingress; Anti-Retraction Valve (ARV) to reduce cross-contamination. Used in general dentistry clinics by trained professionals. Output: mechanical cutting/abrading of dental tissue. Healthcare providers use handpiece to perform restorative procedures; output directly facilitates clinical treatment of dental disease. Benefits: efficient removal of carious material and restoration preparation.

Clinical Evidence

Bench testing only. No clinical data. Performance verified via functional testing against internal specifications and international standards including ISO 14457 (handpieces), ISO 17665-1 (sterilization), and ISO 10993-1 (biocompatibility).

Technological Characteristics

Air-powered dental handpiece; 325,000-450,000 RPM; 0.18-0.30 MPa air pressure; 0.05 N·cm torque. Features Clean Head System and Anti-Retraction Valve. Connects via ISO 9168 compliant couplings (swivel or direct). Sterilization via moist heat (ISO 17665-1).

Indications for Use

Indicated for dental professionals performing caries removal, cavity/crown preparation, removal of dental restorations, and finishing of teeth/restorations. Contraindications not specified.

Regulatory Classification

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.

Predicate Devices

T1 / T2 / T3 Turbine family with serial no. > 600,000 (K131319)
Ti-Max X450 (K112024)

Reference Devices

Mach-Sigma Handpiece, Ultrapush (K980162)
Mach-Sigma Handpiece, Ultrapush, Models Mach-Sigma MU, SU, TU (K991701)

Related Devices

K230888 — Titanium Turbine · Nakanishi, Inc. · Jun 2, 2023
K083101 — PREMIUM SLOW SPEED; 20K AIR MOTOR, HEADS, CONTRA-ANGLES, STRAIGHT NOSECONES · Sable Industries, Inc. · Feb 23, 2009
K991701 — MACH-SIGMA HANDPIECE, ULTRAPUSH, MODELS MACH-SIGMA MU (MINI HEAD), MACH-SIGMA SU (STD. HEAD), MACH-SIGMA TU (TORQUE HD) · Nsk Nakanishi, Inc. · Aug 10, 1999
K141886 — MDK HANDPIECES · Modern Korea Co., Ltd. · May 13, 2015
K150798 — Codent Low Speed Dental Handpieces and Accessories · Codent Technical Industry Co., Ltd. · Apr 24, 2015

Submission Summary (Full Text)

{0}------------------------------------------------ Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the square are the words "U.S. FOOD & DRUG" in blue, with the word "ADMINISTRATION" below it. June 21, 2022 NAKANISHI INC. % Kelby Villarreal Biomedical Engineer Ken Block Consulting LLC 800 East Campbell Road, Suite 202 Richardson. Texas 75081 Re: K203791 Trade/Device Name: Stainless Turbine Regulation Number: 21 CFR 872.4200 Regulation Name: Dental Handpiece And Accessories Regulatory Class: Class I, reserved Product Code: EFB Dated: May 20, 2022 Received: May 23, 2022 Dear Kelby Villarreal: 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 {1}------------------------------------------------ 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 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, For Michael E. Adjodha, M.ChE. 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) K203791 Device Name Stainless Turbine Indications for Use (Describe) 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 coupling is intended for the following applications: A connection device to transfer energy (air, water, light) required for handpieces. | 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: > Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov "An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number." {3}------------------------------------------------ | 510(k) SUMMARY | | K203791 | |--------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Submitter: | NAKANISHI INC. 700 Shimohinata Kanuma Tochigi 322-8666 Japan | | | Contact Person: | Mr. Masaaki Kikuchi General Manager, Regulatory Affairs Dept. TEL: +81-289-64-7277 FAX: +81-289-62-9738 m-kikuchi@nsk-nakanishi.co.jp | | | Date Prepared: | June 17, 2022 | | | Submission Type: | Traditional 510(k) | | | Subject Device: | Clearance: Manufacturer: Trade Name: Common Name: Regulatory Class: Classification Name: Product Code: Regulation: | K203791 NAKANISHI INC. Stainless Turbine Handpiece, Air-Powered, Dental Class I Dental handpiece and accessories EFB 872.4200 | | Primary Predicate Device: | Clearance: Manufacturer: Trade Name: Common Name: Regulatory Class: Classification Name: Product Code: Regulation: | K131319 Sirona Dental Systems GmbH T1 / T2 / T3 Turbine family with serial no. > 600,000 Handpiece, Air-Powered, Dental Class I Dental handpiece and accessories EFB 872.4200 | | Secondary Predicate Device: | Clearance: Manufacturer: Trade Name: Common Name: Regulatory Class: Classification Name: Product Code: Regulation: | K112024 NAKANISHI INC. Ti-Max X450 Handpiece, Air-Powered, Dental Class I Dental handpiece and accessories EFB 872.4200 | | 510(k) SUMMARY | K203791 | | | Reference Device: Clearance: | K980162 | | | Manufacturer: | NAKANISHI INC. | | | Trade Name: | Mach-Sigma Handpiece, Ultrapush | | | Common Name: | Handpiece, Air-Powered, Dental | | | Regulatory Class: | Class I | | | Classification Name: | Dental handpiece and accessories | | | Product Code: | EFB | | | Regulation: | 872.4200 | | | Reference Device: Clearance: | K991701 | | | Manufacturer: | NAKANISHI INC. | | | Trade Name: | Mach-Sigma Handpiece, Ultrapush, Models Mach-Sigma MU (Minihead), Mach-Sigma SU (Standard Head), Mach- Sigma TU (Torque Head) | | | Common Name: | Handpiece, Air-Powered, Dental | | | Regulatory Class: | Class I | | | Classification Name: | Dental handpiece and accessories | | | Product Code: | EFB | | | Regulation: | 872.4200 | | | Device Description: | The Stainless Turbine handpieces are air driven dental handpieces for use by a trained professional in the field of general dentistry. The handpieces are air-powered, high- speed dental handpieces capable of reaching rotational speeds of 325,000 to 450,000 revolutions per minute. Handpiece models include fiber optic, LED, and non-optic lighting. The handpiece models are available to connect directly to NAKANISHI INC. manufactured couplings. Available handpiece models include the S-Max M Series, Pana-Max Plus Series, Pana-Max Plus2 Series, and the S-Max pico Series. The Stainless Turbine couplings are connection devices used to attach the dental unit to the Stainless Turbine handpieces. Available coupling models include the Glass Fiber Rod Series, LED Series, and No Light Irradiation Series. | | | Indications for Use: | 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 coupling is intended for the following applications: A connection device to transfer energy (air, water, light) required for handpieces. | | # Page 1 of 11 NAKANISHI INC. {4}------------------------------------------------ Summary of The Stainless Turbine handpieces are intended for use with a friction grip bur that Technological conforms to ISO 1797-1 standard. The handpieces are capable of achieving rotational Characteristics: speeds of 325,000 to 450,000 revolutions per minute when provided with a supply air pressure of 0.18 to 0.30 MPa. This provides a torque of at least 0.05 N·cm, while {5}------------------------------------------------ #### K203791 generating a noise level of 80 dBA or less. All models include an air-water spray feature that is directed to the bur in order to cool down the operating area. The Stainless Turbine handpiece models of the S-Max M and S-Max pico series have a one-touch quick connect coupling system that allows for the attachment of couplings to the handpieces. When the handpiece and coupling are joined together, a locking mechanism functions to prevent the handpiece from being removed from the coupling during use. The connection mechanism of the handpiece and coupling also has a swivel adapter which allows the handpiece to swivel when connected to the coupling and dental unit. The coupling and hose of the dental unit will be connected using a 5-, 4-, 3-, or 2-hole connector that meets ISO 9168 specifications. The Stainless Turbine handpieces of the Pana-Max Plus and Pana-Max Plus2 series connect directly to the hose of the dental unit. Direct connection to the dental unit can be made with a 4-hole connection that also meets ISO 9168 specifications. All Stainless Turbine handpieces are equipped with a Clean Head System (CHS). which is intended to reduce the ingress of foreign matter into the handpiece, and all Stainless Turbine couplings have an integrated Anti-Retraction Valve (ARV), which is intended to help reduce cross-contamination in the water lines of the handpiece and dental unit. Tables 1 and 2 provide a comparison of the proposed device to both the predicate and reference devices. The tables illustrate the similarities and difference between the devices. {6}------------------------------------------------ ### K203791 | | Proposed Device | Primary Predicate | Secondary Predicate | |-----------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | | Stainless Turbine | T1 / T2 / T3 Turbine family with serial no. > 600,000 | Ti-Max X450 | | 510(k) Submitter [Number] | NAKANISHI INC. [K203791] | Sirona Dental Systems GmbH [K131319] | NAKANISHI INC. [K112024] | | Indications for Use | 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 Coupling is intended for the following applications: A connection device to transfer energy (air, water, light) required for handpieces. | The turbines of the T1 / T2 / T3 Turbine family are intended for the Preparation of cavities and crowns, Removal of carious material, Removal of fillings, Processing of tooth and restoration surfaces, Reducing hard tooth structure. | The Ti-Max X450 is an air-powered dental handpiece with intended use of being a surgical tool for impacted third molar removal and periodontal procedures for which a conventional handpiece would be used. The Ti-Max X450 is intended for use with a friction grip bur that conforms to ISO 1797-1 standard. Recommended supply air pressure is between 0.22 and 0.30 MPa, which results in high speed bur rotation (approximately 380,000 to 450,000 RPM). | | Model Numbers | Handpiece Series S-Max M: M500, M500L, M500K, M500KL, M500SL, M600, M600L, M600K, M600KL, M600SL, M600WLED, M800, M800L, M800KL, M800WL, M900, M900L, M900K, | T1 Turbines T1 Control: T1 Control S, T1 Control K, T1 Control W, T1 Control N T1 Boost: T1 Boost S, T1 Boost K, T1 Boost W, T1 Boost N | X450L, X450KL, X450SL, X450STL, X450WHL, X450MWL, X450M4, X450, X450 5H, X450BLED, X450WLED | | | Proposed Device | Primary Predicate | Secondary Predicate | | | Stainless Turbine | T1 / T2 / T3 Turbine family with serial no. > 600,000 | Ti-Max X450 | | | M900KL, M900W, M900WL | T1 mini: T1 mini S, | | | | Pana-Max Plus: PAP-MU M4, PAP-SU M4 | T1 mini K, T1 mini W, TI mini N | | | | Pana-Max Plus2: PAP2-MU M4, PAP2-SU M4 | T2 Turbines | | | | S-Max pico: S-Max pico, S-Max pico KL, S-Max pico SL, | | | | | S-Max pico BLED, S-Max pico WLED, S-Max pico WHL, S-Max pico MWL, S-Max pico STL | T2 Control: T2 Control S, T2 Control K, T2 Control W, T2 Control N | | | | Coupling Series | T2 Boost: T2 Boost S, T2 Boost K, T2 Boost W, T2 Boost N | | | | LED: PTL-CL-LED, PTL-CL-LED III, KCL-LED | | | | | Glass Fiber Rod: PTL-CL-FV-T | T2 mini: T2 mini S, T2 mini K, T2 mini W, T2 mini N | | | | No Light Irradiation: FM-CL-M4, FM-CL-M4-T, QD-J B2/B3, QD-J M4 | | | | | | T3 Turbines T3 Boost: T3 Boost S, T3 Boost K, T3 Boost W, T3 Boost NQ | | | | | T3 mini: T3 mini S, T3 mini K, T3 mini W, T3 mini NQ | | | Power Source | Compressed Air, Lighting powered by Dental Unit | Compressed Air, Lighting powered by Dental Unit | Compressed Air, Lighting powered by Dental Unit | | Device Features | Clean Head System and Anti-Retraction Value | Information Not Available | Clean Head System and Anti-Retraction Value | | | Proposed | Primary | Secondary | | | Device | Predicate | Predicate | | | Stainless Turbine | T1 / T2 / T3 Turbine family with serial no. > 600,000 | Ti-Max X450 | | Coupling Dimensions or Type | Direct Connection to 4-hole types. (ISO 9168) Connection via swivel adapter to 5-, 4-, 3-, and 2-hole types. (ISO 9168) *1 | Connection to 4- and 6-hole types. (ISO 9168) | Direct Connection to 4- and 5-hole types. (ISO 9168) Connection via swivel adapter to 4-, 3-, and 2-hole types. (ISO 9168) | | Accessories | Handpiece Series Spray Nozzle: Excluding PAP-MU M4, PAP-SU M4, PAP2-MU M4, PAP2-SU M4 Cleaning Wire: All handpiece models Head Cap Wrench: All handpiece models Coupling Series KCL Coupling Wrench: KCL-LED PTL Coupling Wrench: PTL-CL-LED, PTL-CL-LED III, PTL-CL-FV-T, FM-CL-M4, FM-CL-M4-T | Sirona connection spray adapter KaVo connection spray adapter W&H connection spray adapter NSK MachLite connection spray adapter NSK QD-J connection spray adapter Morita connection spray adapter Yoshida connection spray adapter Black nozzle adapter Spray water cartridge T1 Spray Chuck tester | Spray Nozzle: Excluding X450M4, X450 5H Cleaning Wire: All handpiece models PTL O-ring Set: Included in the package X450L, X450 | | Rotation Speed | 325,000 - 450,000 min-1 | 250,000 - 400,000 min-1 | 380,000 – 450,000 min-1 | | | Proposed Device | Primary Predicate | Secondary Predicate | | | Stainless Turbine | T1 / T2 / T3 Turbine family with serial no. > 600,000 | Ti-Max X450 | | Torque | $\geq$ 0.05 N·cm | Information Not Available | $\geq$ 0.09 N·cm…