(27 days)
No
The description focuses on mechanical components, gear ratios, and material changes. There is no mention of AI, ML, or any computational processing of data for decision-making or analysis.
No
The device is described as a cutting and grinding tool for teeth and filling materials, which is not a therapeutic function.
No
Explanation: The device is described as a dental handpiece used for cutting and grinding teeth, cavity preparations, tooth and crown preparations, finishing and trimming teeth and filling materials, and removal of crowns and filling materials. These are all therapeutic and restorative actions, not diagnostic ones.
No
The device description clearly details a physical, mechanical device (contra-angle dental handpiece) with gears, a chuck, and a switching valve, powered by air or electronic motors. It is not software-only.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states the device is for "cutting and grinding teeth, cavity preparations, tooth and crown preparations, finishing and trimming teeth and filling materials." This describes a mechanical action performed directly on the patient's teeth.
- Device Description: The description details how the device transmits rotational force to a dental bur for cutting and grinding. It also mentions features like fiber optics for illumination and water spray options. These are all related to a mechanical dental procedure.
- Lack of IVD Characteristics: An IVD device is used to examine specimens derived from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening. This device does not interact with or analyze such specimens.
The device is a dental handpiece used for performing procedures directly on the patient's teeth, which falls under the category of a surgical or procedural device, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The General Cutting Contra Handpiece is powered by either an air-motor or electronic micromotor for use in general dentistry. The device is intended for cutting and grinding teeth, cavity preparations, tooth and crown preparations, finishing and trimming teeth and filling materials.
Product codes
EGS
Device Description
The subject modified General Cutting Contra Handpiece (modified Ti-Max Z Series: Z10L, Z15L, Z25L, Z85L, Z95L) is a contra-angle dental handpiece powered by either an air-motor or electronic-micromotor for use in general dentistry. The modified General Cutting Contra Handpiece is intended for cutting and grinding teeth, cavity preparations, tooth and crown preparations, finishing and trimming teeth and filling materials, and removal of crowns and filling materials. The modified General Cutting Contra Handpiece transmits rotational force from the motor to the gears through a clutch. The allowable maximum speed for the motor is 40,000 min-1. Then the rotation force reaches the chuck and the dental bur receives the rotation force. The dental bur cuts and grinds teeth using the rotation force. The rotation speed varies depending on the gear ratios as follows:
Z95L 1:5 Increasing
Z85L 1:5 Increasing
Z25L 1:1 Direct Drive
Z15L 4:1 Reducing
Z10L 16:1 Reducing
The modified General Cutting Contra Handpiece feature fiber optic providing illumination to the cutting area.
The subject of this Special 510(k) submission is an addition of the Switching Valve that allows to alternate between two types of water spray options: water spray (water + air) and water jet (water only) to the cleared device [K182999] to reduce the area of irrigation water splattering. This alternation is enabled using the Wrench accessory that has been previously cleared as a part of K121901. The coating material for the exterior of the handpiece has been changed from DURACOAT (Ti+MRK-T) to DURAGRIP (Ti+CrN). The coating material was previously used in the exterior of the nano Series of the predicate General Cutting Contra Handpiece [K182999] and has been cleared by FDA in 2019.
The original submission [K182999] included four series of contra handpieces: the S-Max M Series, the Ti-Max X Series, the Ti-Max Z Series, and the Ti-Max nano Series. The proposed modification applies solely to the Ti-Max Z series. The following models will be affected by this change: Z10L, Z15L, Z25L, Z85L, Z95L. The modified models are marked with "SW" on the neck on the handpiece.
The models that were cleared under the original General Cutting Contra Handpieces submission are not impacted by the present submission.
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
Dentistry / 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
The fundamental scientific technology of the General Cutting Contra Handpiece has not been modified. The risks and hazardous impacts of the device modification were analyzed by FMEA methodology. The specific risk control and protective measures to mitigate the risks from the modification were reviewed and implemented as part of product design. The overall assessment concluded that all identified risks and hazardous conditions were successfully mitigated and accepted.
Testing confirmed that the General Cutting Contra Handpiece device complies with the applicable technical standards, internal specifications, and FDA guidance documents and is safe and effective for its intended use.
Cleaning and sterilization validation testing presented in the predicate 510(k) clearance [K182999] is leveraged to demonstrate that the product continues to meet established performance requirements.
The biocompatibility testing was not repeated as the subject device is made from the same material, same manufacturing processes, and same packaging configuration as those utilized in the fabrication of both the predicate [K182999] and reference devices [K121901]. The biocompatibility testing conducted on the predicate and reference devices ensures that the modified General Cutting Contra Handpiece has a safe biocompatibility profile and is safe to use.
Clinical testing was not required for a determination of substantial equivalence of the modified General Cutting Contra Handpiece.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 872.4200 Dental handpiece and accessories.
(a)
Identification. A dental handpiece and accessories is an AC-powered, water-powered, air-powered, or belt-driven, hand-held device that may include a foot controller for regulation of speed and direction of rotation or a contra-angle attachment for difficult to reach areas intended to prepare dental cavities for restorations, such as fillings, and for cleaning teeth.(b)
Classification. Class I.
0
Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, with the letters "FDA" in a blue square. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
October 27, 2020
Nakanishi Inc. % Yulia Nikova Regulatory Project Manager Ken Block Consulting LLC 800 East Campbell Road, Suite 202 Richardson. Texas 75081
Re: K202960
Trade/Device Name: General Cutting Contra Handpiece Regulation Number: 21 CFR 872.4200 Regulation Name: Dental handpiece and accessories Regulatory Class: Class I, reserved Product Code: EGS Dated: September 29, 2020 Received: September 30, 2020
Dear Yulia Nikova:
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 medical devices and radiation-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 Srinivas "Nandu" Nandkumar, Ph.D. Director DHT1B: Division of Dental Devices OHT1: Office of Ophthalmic, Anesthesia, Respiratory, ENT and Dental Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known)
Device Name General Cutting Contra Handpiece
Indications for Use (Describe)
The General Cutting Contra Handpiece is powered by either an air-motor or electronic micromotor for use in general dentistry. The device is intended for cutting and grinding teeth, cavity preparations, tooth and crown preparations, finishing and trimming teeth and filling materials.
| 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
5. 510(K) SUMMARY K202960
| Submitter: | NAKANISHI INC.
700 Shimohinata
Kanuma, Tochigi 322-8666 Japan | |
|-------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person: | Mr. Masaaki Kikuchi
General Manager/Quality & Regulatory Affairs Dept.
TEL: +81-289-64-7277
FAX: +81-289-62-9738
email: m-kikuchi@nsk-nakanishi.co.jp | |
| Date Prepared: | September 29, 2020 | |
| Submission Type: | Special 510(k) | |
| Subject Device: | Manufacturer:
Trade Name:
Common Name:
Regulatory Class:
Product Code:
Regulation: | NAKANISHI INC.
General Cutting Contra Handpiece
Handpiece, Contra- And Right-Angle Attachment,
Dental
Class I
EGS
21 CFR 872.4200, Dental handpiece and accessories |
| Predicate Device: | Clearance:
Manufacturer:
Trade Name:
Common Name:
Regulatory Class:
Classification Name:
Product Code:
Regulation: | K182999 dated April 16, 2019
NAKANISHI INC.
General Cutting Contra Handpiece
Handpiece, Contra- And Right-Angle Attachment,
Dental
Class I
Handpiece, Contra- And Right-Angle Attachment,
Dental
EGS
21 CFR 872.4200, Dental handpiece and accessories |
| Reference device: | Clearance:
Manufacturer:
Trade Name:
Regulatory Class:
Classification Name:
Product Code:
Regulation: | K121901 dated February 28, 2013
NAKANISHI INC.
Ti-Max Z45
Class I
Handpiece, Contra- And Right-Angle Attachment,
Dental
EGS
21 CFR 872.4200, Dental handpiece and accessories |
| Reference device: | Clearance:
Manufacturer:
Trade Name:
Regulatory Class:
Classification Name:
Product Code:
Regulation: | K173905 dated June 19, 2018
NAKANISHI INC.
Surgic Pro, Surgic Pro+
Class I
Controller, Foot, Handpiece And Cord
EBW
21 CFR 872.4200, Dental handpiece and accessories |
Section 5: Page 1 of 5
NAKANISHI INC.
4
Device Description: The subject modified General Cutting Contra Handpiece (modified Ti-Max Z Series: Z10L, Z15L, Z25L, Z85L, Z95L) is a contra-angle dental handpiece powered by either an air-motor or electronic-micromotor for use in general dentistry. The modified General Cutting Contra Handpiece is intended for cutting and grinding teeth, cavity preparations, tooth and crown preparations, finishing and trimming teeth and filling materials, and removal of crowns and filling materials. The modified General Cutting Contra Handpiece transmits rotational force from the motor to the gears through a clutch. The allowable maximum speed for the motor is 40,000 min-1. Then the rotation force reaches the chuck and the dental bur receives the rotation force. The dental bur cuts and grinds teeth using the rotation force. The rotation speed varies depending on the gear ratios as follows:
| Z95L | 1:5 Increasing |
|---|---|
| Z85L | 1:5 Increasing |
| Z25L | 1:1 Direct Drive |
| Z15L | 4:1 Reducing |
| Z10L | 16:1 Reducing |
The modified General Cutting Contra Handpiece feature fiber optic providing illumination to the cutting area.
The subject of this Special 510(k) submission is an addition of the Switching Valve that allows to alternate between two types of water spray options: water spray (water + air) and water jet (water only) to the cleared device [K182999] to reduce the area of irrigation water splattering. This alternation is enabled using the Wrench accessory that has been previously cleared as a part of K121901. The coating material for the exterior of the handpiece has been changed from DURACOAT (Ti+MRK-T) to DURAGRIP (Ti+CrN). The coating material was previously used in the exterior of the nano Series of the predicate General Cutting Contra Handpiece [K182999] and has been cleared by FDA in 2019.
The original submission [K182999] included four series of contra handpieces: the S-Max M Series, the Ti-Max X Series, the Ti-Max Z Series, and the Ti-Max nano Series. The proposed modification applies solely to the Ti-Max Z series. The following models will be affected by this change: Z10L, Z15L, Z25L, Z85L, Z95L. The modified models are marked with "SW" on the neck on the handpiece.
The models that were cleared under the original General Cutting Contra Handpieces submission are not impacted by the present submission.
5
Indication for Use: The Indication for Use statement is identical to the predicate device. The intended use of the modified device, as described in the labeling, has not changed as a result of the modification.
The General Cutting Contra Handpiece is powered by either an air-motor or electronic micromotor for use in general dentistry. The device is intended for cutting and grinding teeth, cavity preparations, tooth and crown preparations, finishing and trimming teeth and filling materials.
Summary of Technological Characteristics: Comparison with the predicate device shows the characteristics of the proposed modification (an addition of a switching valve in order to alternate between two types of water spray options: water spray (water + air) and water jet (water only)) to the modified General Cutting Contra Handpiece to be substantially equivalent to the predicate device.
| New Device | Predicate Device | Reference Device | |
|---|---|---|---|
| Trade Name | General Cutting | ||
| Contra Handpiece | General Cutting | ||
| Contra Handpiece | Ti-Max Z45 | ||
| 510(k) Submitter | NAKANISHI INC. | NAKANISHI INC. | NAKANISHI INC. |
| [Number] | [TBD] | [K182999] | [K121901] |
| Product Code(s) | EGS | EGS | EGS |
| Indications for | |||
| Use | The General Cutting | ||
| Contra Handpiece is | |||
| powered by either an | |||
| air-motor or | |||
| electronic | |||
| micromotor for use in | |||
| general dentistry. The | |||
| device is intended for | |||
| cutting and grinding | |||
| teeth, cavity | |||
| preparations, tooth | |||
| and crown | |||
| preparations, | |||
| finishing and | |||
| trimming teeth and | |||
| filling materials and | |||
| removal of crowns | |||
| and filling materials. | The General Cutting | ||
| Contra Handpiece is | |||
| powered by either an | |||
| air-motor or | |||
| electronic | |||
| micromotor for use in | |||
| general dentistry. The | |||
| device is intended for | |||
| cutting and grinding | |||
| teeth, cavity | |||
| preparations, tooth | |||
| and crown | |||
| preparations, | |||
| finishing and | |||
| trimming teeth and | |||
| filling materials and | |||
| removal of crowns | |||
| and filling materials. | Ti-Max Z45 is | ||
| powered by either an | |||
| air-motor or electric | |||
| micromotor for use in | |||
| general dentistry. The | |||
| device is intended for | |||
| cutting and grinding | |||
| teeth, cavity | |||
| preparations, tooth | |||
| and crown | |||
| preparations, | |||
| finishing and | |||
| trimming teeth and | |||
| filling materials, and | |||
| removal of crowns | |||
| and filling materials. | |||
| Application | General Dentistry | General Dentistry | General Dentistry |
| Model Numbers | Z10L, Z15L, | ||
| Z25L, | |||
| Z85L, Z95L | Z10L, Z15L, | ||
| Z25L, | |||
| Z85L, Z95L | Z45, Z45L | ||
| Weight | 57g - 59.5g | 57g - 59.5g | 66.5 g |
6
| Burs | ISO 1797-1
(Type1)
ISO 1797-1
(Type3) | ISO 1797-1
(Type1)
ISO 1797-1
(Type3) | ISO 1797-1
(Type3)
φ1.59-1.60mm FG
Bur |
|----------------------------------------------------|------------------------------------------------|------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | ISO 3964 (EN ISO
3964) | ISO 3964 (EN ISO
3964) Standard | ISO 3964 |
| Coupling Type | Standard Coupling | Coupling | |
| Max Rotation
Speed (motor) | 40,000min-1 max | 40,000min-1 max | 40,000 min-1 max |
| | 16:1 Reduction-
2,500min-1 | 16:1 Reduction-
2,500min-1 | |
| | 4:1 Reduction-
10,000min-1 | 4:1 Reduction-
10,000min-1 | |
| Gear Ratio
Max rotation
speed
(handpiece) | 1:1 Direct Drive-
40,000min-1 | 1:1 Direct Drive-
40,000min-1 | 168,000 min-1 |
| | 1:5 Increasing-
200,000min-1 | 1:5 Increasing-
200,000min-1 | |
| Cleaners/
Lubricants | | | Cleaners: N/A
Lubricants: NSK
PANA SPRAY
[K052700], NSK
PANA SPRAY
Plus [K131014], or
NSK automatic
handpiece cleaning
and lubrication
system [K081811] |
| | NSK PANA
SPRAY
Plus [K163483] | NSK PANA
SPRAY
Plus [K163483] | |
| | | | |
| | | | |
| | | | |
| | | | |
| Sterilization
Method | Steam Autoclave
(Moist Heat) | Steam Autoclave
(Moist Heat) | Steam Autoclave
(Moist Heat) |
| Sterilization
Standard | ISO
17665-1:2006 | ISO
17665-1:2006 | ISO
17665-1:2006 |
| | | | |
Summary of Performance Testing:
The fundamental scientific technology of the General Cutting Contra Handpiece has not been modified. The risks and hazardous impacts of the device modification were analyzed by FMEA methodology. The specific risk control and protective measures to mitigate the risks from the modification were reviewed and implemented as part of product design. The overall assessment concluded that all identified risks and hazardous conditions were successfully mitigated and accepted.
Testing confirmed that the General Cutting Contra Handpiece device complies with the applicable technical standards, internal specifications, and FDA guidance documents and is safe and effective for its intended use.
Section 5: Page 4 of 5
7
| | Cleaning and sterilization validation testing presented in the predicate 510(k)
clearance [K182999] is leveraged to demonstrate that the product continues to
meet established performance requirements. |
|--------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Biocompatibility
Testing: | The biocompatibility testing was not repeated as the subject device is made from
the same material, same manufacturing processes, and same packaging
configuration as those utilized in the fabrication of both the predicate [K182999]
and reference devices [K121901]. The biocompatibility testing conducted on the
predicate and reference devices ensures that the modified General Cutting
Contra Handpiece has a safe biocompatibility profile and is safe to use. |
| Discussion of the
Clinical Tests: | Clinical testing was not required for a determination of substantial equivalence
of the modified General Cutting Contra Handpiece. |
| Conclusion: | NAKANISHI INC. considers the modified General Cutting Contra Handpiece
to be substantially equivalent to the predicate device listed above. This
conclusion is based on the similarities in primary intended use, principles of
operation, functional design, materials, and established medical use. |