(131 days)
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.
The General Cutting Straight is a prescription-only dental straight handpiece used by qualified dental healthcare professionals in general dentistry. The General Cutting Straight includes six models: X65L, X65, M65, FX65m, FX65, and EX-5B. The General Cutting Straight conforms to ISO 14457 and is driven by an ISO 3964-compliant electric or air motor. The General Cutting Straight achieves its intended use in conjunction with an ISO 1797-compliant rotary instrument or a prophy angle that conforms to either ANSI ADA Standard No. 85-2004 (R2009) or ISO 14457. The General Cutting Straight is composed mainly of stainless steel, titanium, or aluminum, depending on the model, and is reusable, requiring cleaning and steam sterilization. The accessories of the General Cutting Straight include the Bur Stopper, Bur Stopper Puller, and E-Type Spray Nozzle. The General Cutting Straight is lubricated with the PANA SPRAY Plus [K163486] using the E-Type Spray Nozzle.
This document describes the 510(k) summary for the "General Cutting Straight" dental handpiece. It details its intended use, technological characteristics, and comparison to a predicate device. However, this document does not contain information about a study proving the device meets specific performance acceptance criteria beyond general statements that it met applicable tests from ISO 14457:2017.
The device in question, "General Cutting Straight," is a dental handpiece, which is a mechanical device. The clearance is based on substantial equivalence to a predicate device, not on clinical performance data from an AI or imaging-based diagnostic system. Therefore, the specific questions related to AI/imaging device performance (e.g., sample sizes for test and training sets, expert consensus, MRMC studies, ground truth establishment) are not applicable to this submission type.
Here’s a breakdown of why many of your specific requests cannot be fulfilled from the provided document:
- Type of Device: This is a Class I basic mechanical dental instrument (a handpiece), not an AI/imaging diagnostic device. Substantial equivalence for such devices typically relies heavily on non-clinical performance testing (e.g., safety, mechanical function, biocompatibility) and comparison of specifications to a legally marketed predicate, rather than human-in-the-loop clinical efficacy studies with ground truth derived from expert consensus on images.
- Regulatory Pathway: This is a 510(k) submission for a Class I device. Clinical data is often not required for Class I devices, especially when substantial equivalence can be demonstrated through non-clinical means. The document explicitly states: "Clinical testing was not required as the differences from the predicate device are minor and non-clinical testing is believed to be sufficient for a determination of substantial equivalence of the General Cutting Straight."
Given the nature of the device and the provided document, here's what can be extracted and why other questions are not applicable:
Acceptance Criteria and Device Performance (as far as provided for this mechanical device type):
The document states that NAKANISHI INC. conducted performance testing in accordance with ISO 14457:2017 "Dentistry - Handpieces and motors" and that "All acceptance criteria for the applicable tests were met."
However, the specific quantitative acceptance criteria and the numerical results of the "reported device performance" are not detailed in this summary. The summary only provides qualitative confirmation of compliance with the standard.
| Acceptance Criteria (General) | Reported Device Performance (General) |
|---|---|
| Compliance with ISO 14457:2017 ("Dentistry - Handpieces and motors") | All acceptance criteria for the applicable tests were met. |
| Biocompatibility per ISO 10993-1:2018 | Device concluded to be biocompatible (met cytotoxicity, sensitization, intracutaneous reactivity, acute systemic toxicity, material-mediated pyrogenicity tests). |
| Reprocessing Validation per ISO 17665-1:2006 and FDA guidance | Device can be used safely; validated reprocessing instructions included in operation manual. |
Answers to Specific Questions in the Context of this Mechanical Device 510(k):
-
A table of acceptance criteria and the reported device performance:
- As shown above, the document states general compliance with ISO standards (ISO 14457:2017 for performance, ISO 10993-1:2018 for biocompatibility, ISO 17665-1:2006 for reprocessing). Specific quantitative acceptance criteria or numerical performance data are not provided in this 510(k) summary. The "acceptance criteria" listed are the qualitative statements of meeting the standards.
-
Sample sizes used for the test set and the data provenance:
- Not Applicable. This is a mechanical device, not an AI/imaging diagnostic device that uses "test sets" of patient data in the way you are implying for AI algorithm validation. Performance testing was likely conducted on a sample of manufactured devices, but the size and specifics are not provided in this summary. Data provenance (country of origin of data, retrospective/prospective) is not relevant for this type of mechanical device testing.
-
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not Applicable. Ground truth in the context of expert review of images is not relevant for a mechanical dental handpiece. The "ground truth" for this device is its mechanical functionality, safety (biocompatibility), and ability to be reprocessed, which are assessed through engineering and laboratory tests, not human image interpretation.
-
Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not Applicable. Adjudication methods are relevant for resolving discrepancies in expert interpretations, typically in imaging studies. This is not applicable to the performance testing of a mechanical dental handpiece.
-
If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
- Not Applicable. This is a mechanical device, not an AI-assisted diagnostic tool. MRMC studies are designed for evaluating diagnostic AI systems in conjunction with human readers.
-
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not Applicable. This is a mechanical device; there is no "algorithm" to be evaluated in a standalone manner.
-
The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- For this mechanical device, "ground truth" pertains to its engineering specifications, material properties, and functionality under test conditions. This is established through laboratory testing against predefined engineering and biocompatibility standards, not through expert consensus on clinical images or pathology findings.
-
The sample size for the training set:
- Not Applicable. This is a mechanical device; there is no "training set" in the context of machine learning or AI.
-
How the ground truth for the training set was established:
- Not Applicable. As there is no training set for this type of device, ground truth establishment for a training set is not pertinent.
In summary, the provided document is a 510(k) clearance letter and summary for a basic mechanical dental handpiece. It confirms compliance with relevant mechanical and biocompatibility standards but does not detail the specific quantitative results of the performance tests or involve the types of studies (e.g., clinical imaging trials, AI algorithm validation) that would address most of your specific questions.
{0}------------------------------------------------
Image /page/0/Picture/0 description: The image contains the logos of the U.S. Department of Health and Human Services and the U.S. 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 is a blue square with the letters "FDA" in white, followed by the words "U.S. Food & Drug Administration" in blue.
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.
{1}------------------------------------------------
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 (DICE@fda.hhs.gov) or phone (1-800-638-2041 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
{2}------------------------------------------------
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)
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}------------------------------------------------
NSK
| 510(k) Summary | K230106 | |
|---|---|---|
| Applicant/ Sponsor: | NAKANISHI INC.700 ShimohinataKanuma, Tochigi, 322-8666 Japan | |
| Contact Person: | Mr. Masaaki KikuchiGeneral Manager, Quality/Regulatory Affairs Department700 ShimohinataKanuma Tochigi 322-8666 JapanTEL: +81-289-64-7277FAX: +81-289-62-9738Email: m-kikuchi@nsk-nakanishi.co.jp | |
| Date Prepared: | January 13, 2022 | |
| Submission Type: | Traditional 510(k) | |
| New Device: | Manufacturer:Trade Name:Common Name:Classification Name:Product Code:Regulation:Regulatory Class: | NAKANISHI INC.General Cutting StraightDental straight handpieceHandpiece, Contra- And Right-Angle Attachment, DentalEGS§872.4200, Dental Handpiece and AccessoriesI |
| Predicate Device: | Clearance:Manufacturer:Trade Name:Classification Name:Product Code:Regulation:Regulatory Class: | K132356 dated January 31, 2014SciCan GmbHSANAO Dental HandpiecesHandpiece, Contra- And Right-Angle Attachment, DentalEGS§872.4200, Dental Handpiece and AccessoriesI |
| DeviceDescription: | The General Cutting Straight is a prescription-only dental straight handpieceused by qualified dental healthcare professionals in general dentistry. TheGeneral Cutting Straight includes six models: X65L, X65, M65, FX65m, FX65,and EX-5B. The General Cutting Straight conforms to ISO 14457 and is drivenby an ISO 3964-compliant electric or air motor. The General Cutting Straightachieves its intended use in conjunction with an ISO 1797-compliant rotaryinstrument or a prophy angle that conforms to either ANSI ADA Standard No.85-2004 (R2009) or ISO 14457. The General Cutting Straight is composedmainly of stainless steel, titanium, or aluminum, depending on the model, and isreusable, requiring cleaning and steam sterilization. The accessories of theGeneral Cutting Straight include the Bur Stopper, Bur Stopper Puller, and E-Type Spray Nozzle. The General Cutting Straight is lubricated with the PANASPRAY Plus [K163486] using the E-Type Spray Nozzle. | |
| Principle ofOperation /Mechanism ofAction: | The General Cutting Straight is driven by an ISO 3964-compliant electric or airmotor and transmits the rotational force through the internal spindle to themounted rotary instruments for achieving its intended use. The models whosetransmission ratio is 1:1 transmit the rotational speed as is from the motor to themounted instrument. The model whose ratio is 4:1 includes a speed reducinggear mechanism and slows down the rotational speed to ¼ prior to transmittingthe 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(fillings and prostheses), finishing and polishing of teeth and dental restorations. | ||
| FX65/FX65m/EX-5BGeneral 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 dentalrestorations. | ||
| 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. |
{4}------------------------------------------------
510(k) Summary
Technological Characteristics:
| New Device | Predicate Device | |
|---|---|---|
| Trade/DeviceName | General Cutting Straight | SANAO Dental Handpieces |
| 510(k) Submitter[K Number] | NAKANISHI INC.[TBD] | SciCan GmbH[K132356] |
| Product Code | EGS | EGS |
| ClassificationName | Handpiece, Contra- And Right-AngleAttachment, Dental | Handpiece, Contra- And Right-AngleAttachment, Dental |
| Regulation | 21 CFR 872.4200Dental Handpiece and Accessories | 21 CFR 872.4200Dental Handpiece and Accessories |
| Device Class | I | I |
| Indications forUse | X65L/X65/M65General Cutting Straight is intended for thefollowing application(s):Caries removal, cavity and crownpreparation, removal of dental restorations(fillings and prostheses), finishing andpolishing of teeth and dental restorations.FX65/FX65m/EX-5BGeneral Cutting Straight is intended for thefollowing application(s):Caries removal, cavity and crownpreparation, removal of dental restorations(fillings and prostheses), finishing andpolishing of teeth and dental restorations.Using a prophy angle, prophylaxistreatment of the surface of teeth and dentalrestorations. | This medical device is only intendedfor dental treatment in the area ofdentistry. It is intended to be used forthe following applications:• SANAO 200L/40ST: The removal ofdecayed matter, cavity and crownpreparations, the removal of fillingsand surface finishing of tooth andrestoration surfaces.• SANAO 40/40L/10/10L: Cavitypreparations, caries excavation,endodontics, surface finishing of toothand restoration surfaces.• SANAO PSI/PSO: prophylaxistreatment. |
| Rx/OTC Use | Rx Only | Rx Only |
| Application | General dentistry and prophylaxis | General dentistry and prophylaxis |
| New Device | Predicate Device | |
| Trade/DeviceName | General Cutting Straight | SANAO Dental Handpieces |
| Models | General dentistry:X65, X65, M65General dentistry & Prophylaxis:FX65m, FX65, EX-5B | General dentistry:SANAO 200L, 40STSANAO 40, 40L, 10, 10LProphylaxis: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 withMotor | ISO 3964 | ISO 3964 |
| Maximum InputSpeed | 40,000 min-1 | 40,000 min-1 |
| TransmissionRatio | 1:1X65L, X65, M65, FX65m, FX654:1EX-5B | 1:1SANAO 40, 40L, 40ST5:1SANAO 10, 10L, PSI, PSO1:5SANAO 200L |
| Maximum OutputSpeed | 10,000 min-1:EX-5B40,000 min-1:X65L, X65, M65, FX65m, FX65 | 8,000 min-1:SANAO 10 10L, PSI, PSO40,000 min-1:SANAO 40, 40L, 40ST200,000 min-1:SANAO 200L |
| Type of Chuck | Mechanical Chuck (Bur Lock Ring): Allmodels | Push Button:SANAO 200L, 40, 40L, 10, 10LMechanical Chuck (Clamping ring):SANAO 40STNot Applicable:SANAO PSI, PSO |
| Burs | ISO 1797 Type 1X65L, X65, M65 (Ø2.334-2.35 mm)ISO 1797 Type 2X65L, X65, M65, FX65m, FX65,EX-5B (Ø2.334-2.35 mm) | ISO 1797 Type 1SANAO 40, 40L (Ø2.35 mm)SANAO 10, 10L (Ø 2.35 mm)ISO 1797 Type 2SANAO 40ST (Ø 2.35 mm)ISO 1797 Type 3SANAO 200L (Ø 1.60 mm) |
| Prophy Angles | FX65m, FX65, EX-5B with prophy anglesconforming to ANSI ADA Standard No.85-2004 (R2009) or ISO 14457 | PSI with Screw-In-Function (with ISO13295 Type 3)PSO with mandrels with Snap-on-Function (ISO 13295 Type 5) |
{5}------------------------------------------------
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
{6}------------------------------------------------
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
§ 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.