(131 days)
No
The device description and performance studies focus on mechanical and material properties, sterilization, and biocompatibility, with no mention of AI or ML.
No
The device is described as a "dental straight handpiece" used for procedures like "caries removal, cavity and crown preparation, removal of dental restorations..., finishing and polishing of teeth and dental restorations." These are restorative and preparatory functions, not explicitly therapeutic in the sense of treating disease or dysfunction other than removal of diseased tissue.
No
Explanation: The device description states its intended use for procedures like caries removal, cavity preparation, and finishing/polishing of teeth, which are treatment-oriented rather than diagnostic. It does not mention any function for identifying or assessing a medical condition.
No
The device description clearly states it is a "dental straight handpiece" composed of physical materials like stainless steel, titanium, or aluminum. It also mentions accessories and lubrication, indicating a hardware component.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens taken from the human body (like blood, urine, or tissue) to provide information about a person's health.
- Device Function: The description clearly states that this device is a dental handpiece used for mechanical procedures on teeth and dental restorations (caries removal, cavity preparation, etc.). It operates directly on the patient's mouth.
- Intended Use: The intended use is focused on physical manipulation and treatment within the oral cavity, not on analyzing biological samples.
- Device Description: The description details the mechanical components and how it's used with rotary instruments or prophy angles, all of which are for physical procedures.
- Performance Studies: The performance studies focus on mechanical performance (ISO 14457), biocompatibility (ISO 10993), and reprocessing (ISO 17665-1), which are relevant to a medical device used in the body, not an IVD.
The device is a medical device, specifically a dental handpiece, but it does not fit the definition of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
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.
Product codes (comma separated list FDA assigned to the subject device)
EGS
Device Description
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
teeth
Indicated Patient Age Range
Not Found
Intended User / Care Setting
qualified dental healthcare professionals in general dentistry.
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)
The General Cutting Straight was developed under applicable international standards, specifications, and FDA guidance documents. NAKANISHI INC. validated reprocessing instructions of the subject device based on 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" 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
- 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 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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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 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)
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3
NSK
| 510(k) Summary | K230106 | |
|---|---|---|
| Applicant/ Sponsor: | NAKANISHI INC. | |
| 700 Shimohinata | ||
| Kanuma, Tochigi, 322-8666 Japan | ||
| Contact Person: | Mr. Masaaki Kikuchi | |
| General Manager, Quality/Regulatory Affairs Department | ||
| 700 Shimohinata | ||
| Kanuma Tochigi 322-8666 Japan | ||
| TEL: +81-289-64-7277 | ||
| FAX: +81-289-62-9738 | ||
| Email: 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 Straight | ||
| Dental straight handpiece | ||
| Handpiece, Contra- And Right-Angle Attachment, Dental | ||
| EGS | ||
| §872.4200, Dental Handpiece and Accessories | ||
| I | ||
| Predicate Device: | Clearance: | |
| Manufacturer: | ||
| Trade Name: | ||
| Classification Name: | ||
| Product Code: | ||
| Regulation: | ||
| Regulatory Class: | K132356 dated January 31, 2014 | |
| SciCan GmbH | ||
| SANAO Dental Handpieces | ||
| Handpiece, Contra- And Right-Angle Attachment, Dental | ||
| EGS | ||
| §872.4200, Dental Handpiece and Accessories | ||
| I | ||
| Device | ||
| Description: | 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. | ||
| Principle of | ||
| Operation / | ||
| Mechanism of | ||
| Action: | The General Cutting Straight is driven by an ISO 3964-compliant electric or air | |
| motor and transmits the rotational force through the internal spindle to the | ||
| mounted rotary instruments for achieving its intended use. The models whose | ||
| transmission ratio is 1:1 transmit the rotational speed as is from the motor to the | ||
| mounted instrument. The model whose ratio is 4:1 includes a speed reducing | ||
| gear mechanism and slows down the rotational speed to ¼ prior to transmitting | ||
| 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 | ||
| (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. | ||
| 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/Device | ||
| Name | General Cutting Straight | SANAO Dental Handpieces |
| 510(k) Submitter | ||
| [K Number] | NAKANISHI INC. | |
| [TBD] | SciCan GmbH | |
| [K132356] | ||
| Product Code | EGS | EGS |
| Classification | ||
| Name | Handpiece, Contra- And Right-Angle | |
| Attachment, Dental | Handpiece, Contra- And Right-Angle | |
| Attachment, Dental | ||
| Regulation | 21 CFR 872.4200 | |
| Dental Handpiece and Accessories | 21 CFR 872.4200 | |
| Dental Handpiece and Accessories | ||
| Device Class | I | I |
| Indications for | ||
| Use | 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. | This medical device is only intended | |
| for dental treatment in the area of | ||
| dentistry. It is intended to be used for | ||
| the following applications: | ||
| • SANAO 200L/40ST: The removal of | ||
| decayed matter, cavity and crown | ||
| preparations, the removal of fillings | ||
| and surface finishing of tooth and | ||
| restoration surfaces. | ||
| • SANAO 40/40L/10/10L: Cavity | ||
| preparations, caries excavation, | ||
| endodontics, surface finishing of tooth | ||
| and restoration surfaces. | ||
| • SANAO PSI/PSO: prophylaxis | ||
| treatment. | ||
| Rx/OTC Use | Rx Only | Rx Only |
| Application | General dentistry and prophylaxis | General dentistry and prophylaxis |
| New Device | Predicate Device | |
| Trade/Device | ||
| Name | General Cutting Straight | SANAO Dental Handpieces |
| Models | General dentistry: | |
| X65, X65, M65 | ||
| General dentistry & Prophylaxis: | ||
| FX65m, FX65, EX-5B | General dentistry: | |
| SANAO 200L, 40ST | ||
| SANAO 40, 40L, 10, 10L | ||
| Prophylaxis: | ||
| 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 | ||
| Motor | ISO 3964 | ISO 3964 |
| Maximum Input | ||
| Speed | 40,000 min-1 | 40,000 min-1 |
| Transmission | ||
| Ratio | 1:1 | |
| X65L, X65, M65, FX65m, FX65 | ||
| 4:1 | ||
| EX-5B | 1:1 | |
| SANAO 40, 40L, 40ST | ||
| 5:1 | ||
| SANAO 10, 10L, PSI, PSO | ||
| 1:5 | ||
| SANAO 200L | ||
| Maximum Output | ||
| Speed | 10,000 min-1: | |
| EX-5B | ||
| 40,000 min-1: | ||
| X65L, X65, M65, FX65m, FX65 | 8,000 min-1: | |
| SANAO 10 10L, PSI, PSO | ||
| 40,000 min-1: | ||
| SANAO 40, 40L, 40ST | ||
| 200,000 min-1: | ||
| SANAO 200L | ||
| Type of Chuck | Mechanical Chuck (Bur Lock Ring): All | |
| models | Push Button: | |
| SANAO 200L, 40, 40L, 10, 10L | ||
| Mechanical Chuck (Clamping ring): | ||
| SANAO 40ST | ||
| Not Applicable: | ||
| SANAO PSI, PSO | ||
| Burs | ISO 1797 Type 1 | |
| X65L, X65, M65 (Ø2.334-2.35 mm) | ||
| ISO 1797 Type 2 | ||
| X65L, X65, M65, FX65m, FX65, | ||
| EX-5B (Ø2.334-2.35 mm) | ISO 1797 Type 1 | |
| SANAO 40, 40L (Ø2.35 mm) | ||
| SANAO 10, 10L (Ø 2.35 mm) | ||
| ISO 1797 Type 2 | ||
| SANAO 40ST (Ø 2.35 mm) | ||
| ISO 1797 Type 3 | ||
| SANAO 200L (Ø 1.60 mm) | ||
| Prophy Angles | FX65m, FX65, EX-5B with prophy angles | |
| conforming to ANSI ADA Standard No. | ||
| 85-2004 (R2009) or ISO 14457 | PSI with Screw-In-Function (with ISO | |
| 13295 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.