General Cutting Straight

K230106 · Nakanishi, Inc. · EGS · May 24, 2023 · Dental

Device Facts

• Record ID: K230106
• Device Name: General Cutting Straight
• Applicant: Nakanishi, Inc.
• Product Code: EGS · Dental
• Decision Date: May 24, 2023
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.4200
• Device Class: Class 1
• Attributes: Therapeutic

Intended Use

General Cutting Straight is intended for the following application(s): Caries removal, cavity and crown preparation, removal of dental restorations (fillings and prostheses), finishing and polishing of teeth and dental restorations. FX65 / FX65m / EX-5B General Cutting Straight is intended for the following application(s): Caries removal, cavity and crown preparation, removal of dental restorations (fillings and prostheses), finishing and polishing of teeth and dental restorations. Using a prophy angle, prophylaxis treatment of the surface of teeth and dental restorations.

Device Story

Dental straight handpiece; used by dental professionals in general dentistry. Inputs: rotational force from ISO 3964-compliant electric or air motor. Mechanism: internal spindle transmits rotation to mounted rotary instruments (ISO 1797-compliant) or prophy angles; 1:1 transmission ratio models maintain motor speed; 4:1 ratio model (EX-5B) uses speed-reducing gear. Outputs: mechanical rotation for cutting, finishing, polishing, or prophylaxis. Used in clinical dental settings. Healthcare provider operates device manually to perform procedures; output directly affects tissue/restoration removal and surface finishing. Benefits: enables precise dental procedures, caries removal, and restoration maintenance.

Clinical Evidence

No clinical data. Substantial equivalence supported by bench testing, including performance testing per ISO 14457:2017 and biocompatibility evaluation per ISO 10993-1 (cytotoxicity, sensitization, intracutaneous reactivity, acute systemic toxicity, and material-mediated pyrogenicity). Reprocessing instructions validated per ISO 17665-1:2006.

Technological Characteristics

Materials: stainless steel, titanium, or aluminum. Coupling: ISO 3964. Rotary instrument compatibility: ISO 1797. Prophy angle compatibility: ANSI ADA Standard No. 85-2004 or ISO 14457. Transmission: 1:1 or 4:1 gear reduction. Chuck: Mechanical (Bur Lock Ring). Sterilization: Steam. Biocompatibility: ISO 10993-1 compliant.

Indications for Use

Indicated for dental healthcare professionals for caries removal, cavity/crown preparation, removal of dental restorations, and finishing/polishing of teeth/restorations. Select models (FX65, FX65m, EX-5B) also indicated for prophylaxis treatment using a prophy angle.

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

• SANAO Dental Handpieces (K132356)

Submission Summary (Full Text)

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May 24, 2023

Nakanishi Inc. % Dr. Akiko Dohi Regulatory Scientist Ken Block Consulting LLC 800 E Campbell Road, Suite 202 Richardson, Texas 75081

Re: K230106

Trade/Device Name: General Cutting Straight Regulation Number: 21 CFR 872.4200 Regulation Name: Dental Handpiece And Accessories Regulatory Class: Class I, reserved Product Code: EGS Dated: January 13, 2023 Received: January 13, 2023

Dear Dr. Akiko Dohi:

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.

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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 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 ([e-mail]) or phone [phone] or 301-796-7100).

Sincerely.

# Michael E. Adjodha -S

Michael 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

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# Indications for Use

510(k) Number (if known) K230106

Device Name General Cutting Straight

#### Indications for Use (Describe) X65L / X65 / M65

General Cutting Straight is intended for the following application(s):

Caries removal, cavity and crown preparation, removal of dental restorations (fillings and prostheses), finishing and polishing of teeth and dental restorations.

FX65 / FX65m / EX-5B

General Cutting Straight is intended for the following application(s):

Caries removal, cavity and crown preparation, removal of dental restorations (fillings and prostheses), finishing and polishing of teeth and dental restorations. Using a prophy angle, prophylaxis treatment of the surface of teeth and dental restorations.

| Type of Use (Select one or both, as applicable) |
|-------------------------------------------------|
|-------------------------------------------------|

X Prescription Use (Part 21 CFR 801 Subpart D)

Over-The-Counter Use (21 CFR 801 Subpart C)

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# NSK

| 510(k) Summary | | K230106 |
|--------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Applicant/ Sponsor: | NAKANISHI INC.<br>700 Shimohinata<br>Kanuma, Tochigi, 322-8666 Japan | |
| Contact Person: | Mr. Masaaki Kikuchi<br>General Manager, Quality/Regulatory Affairs Department<br>700 Shimohinata<br>Kanuma Tochigi 322-8666 Japan<br>TEL: [phone]<br>FAX: [phone]<br>Email: [e-mail] | |
| Date Prepared: | January 13, 2022 | |
| Submission Type: | Traditional 510(k) | |
| New Device: | Manufacturer:<br>Trade Name:<br>Common Name:<br>Classification Name:<br>Product Code:<br>Regulation:<br>Regulatory Class: | NAKANISHI INC.<br>General Cutting Straight<br>Dental straight handpiece<br>Handpiece, Contra- And Right-Angle Attachment, Dental<br>EGS<br>§872.4200, Dental Handpiece and Accessories<br>I |
| Predicate Device: | Clearance:<br>Manufacturer:<br>Trade Name:<br>Classification Name:<br>Product Code:<br>Regulation:<br>Regulatory Class: | K132356 dated January 31, 2014<br>SciCan GmbH<br>SANAO Dental Handpieces<br>Handpiece, Contra- And Right-Angle Attachment, Dental<br>EGS<br>§872.4200, Dental Handpiece and Accessories<br>I |
| Device<br>Description: | The General Cutting Straight is a prescription-only dental straight handpiece<br>used by qualified dental healthcare professionals in general dentistry. The<br>General Cutting Straight includes six models: X65L, X65, M65, FX65m, FX65,<br>and EX-5B. The General Cutting Straight conforms to ISO 14457 and is driven<br>by an ISO 3964-compliant electric or air motor. The General Cutting Straight<br>achieves its intended use in conjunction with an ISO 1797-compliant rotary<br>instrument or a prophy angle that conforms to either ANSI ADA Standard No.<br>85-2004 (R2009) or ISO 14457. The General Cutting Straight is composed<br>mainly of stainless steel, titanium, or aluminum, depending on the model, and is<br>reusable, requiring cleaning and steam sterilization. The accessories of the<br>General Cutting Straight include the Bur Stopper, Bur Stopper Puller, and E-<br>Type Spray Nozzle. The General Cutting Straight is lubricated with the PANA<br>SPRAY Plus [K163486] using the E-Type Spray Nozzle. | |
| Principle of<br>Operation /<br>Mechanism of<br>Action: | The General Cutting Straight is driven by an ISO 3964-compliant electric or air<br>motor and transmits the rotational force through the internal spindle to the<br>mounted rotary instruments for achieving its intended use. The models whose<br>transmission ratio is 1:1 transmit the rotational speed as is from the motor to the<br>mounted instrument. The model whose ratio is 4:1 includes a speed reducing<br>gear mechanism and slows down the rotational speed to ¼ prior to transmitting<br>the rotation to the mounted instrument. | |
| Statement of | X65L/X65/M65 | |
| Intended Use: | General Cutting Straight is intended for the following application(s): | |
| | Caries removal, cavity and crown preparation, removal of dental restorations<br>(fillings and prostheses), finishing and polishing of teeth and dental restorations. | |
| | FX65/FX65m/EX-5B<br>General Cutting Straight is intended for the following application(s):<br>Caries removal, cavity and crown preparation, removal of dental restorations<br>(fillings and prostheses), finishing and polishing of teeth and dental restorations.<br>Using a prophy angle, prophylaxis treatment of the surface of teeth and dental<br>restorations. | |
| Summary of | Technological characteristics of the General Cutting Straight are briefly | |
| Technological | summarized and compared to those of the predicate device in the table below. | |

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## 510(k) Summary

Technological Characteristics:

| | New Device | Predicate Device |
|--------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Trade/Device<br>Name | General Cutting Straight | SANAO Dental Handpieces |
| 510(k) Submitter<br>[K Number] | NAKANISHI INC.<br>[TBD] | SciCan GmbH<br>[K132356] |
| Product Code | EGS | EGS |
| Classification<br>Name | Handpiece, Contra- And Right-Angle<br>Attachment, Dental | Handpiece, Contra- And Right-Angle<br>Attachment, Dental |
| Regulation | 21 CFR 872.4200<br>Dental Handpiece and Accessories | 21 CFR 872.4200<br>Dental Handpiece and Accessories |
| Device Class | I | I |
| Indications for<br>Use | X65L/X65/M65<br>General Cutting Straight is intended for the<br>following application(s):<br>Caries removal, cavity and crown<br>preparation, removal of dental restorations<br>(fillings and prostheses), finishing and<br>polishing of teeth and dental restorations.<br>FX65/FX65m/EX-5B<br>General Cutting Straight is intended for the<br>following application(s):<br>Caries removal, cavity and crown<br>preparation, removal of dental restorations<br>(fillings and prostheses), finishing and<br>polishing of teeth and dental restorations.<br>Using a prophy angle, prophylaxis<br>treatment of the surface of teeth and dental<br>restorations. | This medical device is only intended<br>for dental treatment in the area of<br>dentistry. It is intended to be used for<br>the following applications:<br>• SANAO 200L/40ST: The removal of<br>decayed matter, cavity and crown<br>preparations, the removal of fillings<br>and surface finishing of tooth and<br>restoration surfaces.<br>• SANAO 40/40L/10/10L: Cavity<br>preparations, caries excavation,<br>endodontics, surface finishing of tooth<br>and restoration surfaces.<br>• SANAO PSI/PSO: prophylaxis<br>treatment. |
| Rx/OTC Use | Rx Only | Rx Only |
| Application | General dentistry and prophylaxis | General dentistry and prophylaxis |
| | New Device | Predicate Device |
| Trade/Device<br>Name | General Cutting Straight | SANAO Dental Handpieces |
| Models | General dentistry:<br>X65, X65, M65<br>General dentistry & Prophylaxis:<br>FX65m, FX65, EX-5B | General dentistry:<br>SANAO 200L, 40ST<br>SANAO 40, 40L, 10, 10L<br>Prophylaxis:<br>SANAO PSI, PSO |
| Materials | Biocompatible per ISO 10993-1 | Biocompatible per ISO 10993-1 |
| Driven by | Electric or air motor | Electric or air motor |
| Coupling with<br>Motor | ISO 3964 | ISO 3964 |
| Maximum Input<br>Speed | 40,000 min-1 | 40,000 min-1 |
| Transmission<br>Ratio | 1:1<br>X65L, X65, M65, FX65m, FX65<br>4:1<br>EX-5B | 1:1<br>SANAO 40, 40L, 40ST<br>5:1<br>SANAO 10, 10L, PSI, PSO<br>1:5<br>SANAO 200L |
| Maximum Output<br>Speed | 10,000 min-1:<br>EX-5B<br>40,000 min-1:<br>X65L, X65, M65, FX65m, FX65 | 8,000 min-1:<br>SANAO 10 10L, PSI, PSO<br>40,000 min-1:<br>SANAO 40, 40L, 40ST<br>200,000 min-1:<br>SANAO 200L |
| Type of Chuck | Mechanical Chuck (Bur Lock Ring): All<br>models | Push Button:<br>SANAO 200L, 40, 40L, 10, 10L<br>Mechanical Chuck (Clamping ring):<br>SANAO 40ST<br>Not Applicable:<br>SANAO PSI, PSO |
| Burs | ISO 1797 Type 1<br>X65L, X65, M65 (Ø2.334-2.35 mm)<br>ISO 1797 Type 2<br>X65L, X65, M65, FX65m, FX65,<br>EX-5B (Ø2.334-2.35 mm) | ISO 1797 Type 1<br>SANAO 40, 40L (Ø2.35 mm)<br>SANAO 10, 10L (Ø 2.35 mm)<br>ISO 1797 Type 2<br>SANAO 40ST (Ø 2.35 mm)<br>ISO 1797 Type 3<br>SANAO 200L (Ø 1.60 mm) |
| Prophy Angles | FX65m, FX65, EX-5B with prophy angles<br>conforming to ANSI ADA Standard No.<br>85-2004 (R2009) or ISO 14457 | PSI with Screw-In-Function (with ISO<br>13295 Type 3)<br>PSO with mandrels with Snap-on-<br>Function (ISO 13295 Type 5) |

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## 510(k) Summary

The General Cutting Straight was developed under applicable international Summary of Non-Clinical/ standards, specifications, and FDA guidance documents. NAKANISHI INC. Performance validated reprocessing instructions of the subject device based on ISO 17665-1:2006 Testing: "Sterilization of health care products — Moist heat — Part 1: Requirements for the development, validation and routine control of a sterilization process for medical

# KANISHI

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### 510(k) Summary

devices" and the FDA guidance document "Reprocessing Medical Devices in Health Care Settings: Validation Methods and Labeling." Based on the validation results, NAKANISHI INC. determined that the subject device can be used safely and included the validated reprocessing instructions in the operation manual of the subject device. The operation manual of the subject device is included in Section 13 Proposed Labeling.

NAKANISHI INC. evaluated the biocompatibility of the subject device based on ISO 10993-1:2018 "Biological evaluation of medical devices — Part 1: Evaluation and testing within a risk management process" and the FDA guidance document "Use of International Standard ISO 10993-1, "Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process"" and included:

- Cytotoxicity per ISO10993-5 ●
- Sensitization per ISO10993-10
- Intracutaneous Reactivity per ISO10993-10 0
- Acute Systemic Toxicity per ISO 10993-11 ●
- Material-Mediated Pyrogenicity per ISO 10993-11 ●

Based on the evaluation, NAKANISHI INC. concluded that the subject device is biocompatible.

NAKANISHI INC. conducted performance testing in accordance with ISO 14457:2017 "Dentistry - Handpieces and motors" for the safety and effectiveness of the subject device. All acceptance criteria for the applicable tests were met.

Together, these verification/validation activities successfully demonstrate that the General Cutting Straight performs as intended and raises no new questions regarding either safety or effectiveness when compared to the predicate device.

- Clinical Clinical testing was not required as the differences from the predicate device are Testing: minor and non-clinical testing is believed to be sufficient for a determination of substantial equivalence of the General Cutting Straight.
- Conclusion: Based on the similarities in intended use, principles of operation, and functional design, demonstrating that the General Cutting Straight is as safe, as effective, and performs as well as the predicate device, NAKANISHI INC. considers the General Cutting Straight to be substantially equivalent to the predicate device identified above.

# NAKANISHI ING