(244 days)
TI-MAX Z45 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 Ti-MAX Z45 is a contra-angle dental handpiece which is powered by either an air-motor or electronic-micromotor for use in general dentistry. The TI-MAX Z45 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 Tr-MAX Z45 transmits rotational force from the motor to the gears through a clutch, and then the rotation force reaches the chuck and the dental bur receives the rotation force. The dental bur is able to cut and grind teeth and dentures using the rotation force.
The provided text describes a 510(k) summary for a dental handpiece, the TI-MAX Z45. This document focuses on demonstrating substantial equivalence to predicate devices through various comparisons and bench testing. It does not contain information about clinical studies with human readers or AI algorithms for diagnostic purposes. Therefore, many of the requested categories related to clinical studies and AI performance cannot be addressed.
Here's the information that can be extracted from the provided text, primarily focusing on the acceptance criteria and the study performed:
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria for the TI-MAX Z45 are based on compliance with the international standard ISO 7785-2, which is also used for the predicate devices.
| Acceptance Criterion | Reported Device Performance |
|---|---|
| Compliance with ISO 7785-2 | All TI-MAX Z45 samples were compliant with ISO 7785-2 |
The text also provides specific performance characteristics, although these are not explicitly labelled as "acceptance criteria" but rather as "performance" metrics within the comparison table:
| Performance Metric | TI-MAX Z45 Reported Value |
|---|---|
| Eccentricity | 0.016 mm |
| Force for bur extraction | 25.3N |
| Flow Rate (Coolant Water) | More than 50 ml/min |
2. Sample Size Used for the Test Set and Data Provenance
The document states that "All TI-MAX Z45 samples were compliant with ISO 7785-2". However, the exact sample size for the bench testing is not specified in the provided text.
The data provenance is from bench testing performed by the manufacturer, NAKANISHI, INC., a company located in Japan. The study is not a clinical study involving patient data and therefore the terms "retrospective or prospective" do not apply in the usual sense.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
Not applicable. The "ground truth" for this device's acceptance was established through compliance with an engineering standard (ISO 7785-2) via bench testing, not through expert clinical interpretation of data.
4. Adjudication Method for the Test Set
Not applicable. This was bench testing against a standard, not a clinical study requiring adjudication of expert opinions.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. This document describes the regulatory submission for a physical dental handpiece, not an AI software or a diagnostic tool that would typically involve human readers and comparative effectiveness studies.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
No. This is a hardware device (dental handpiece), not an algorithm or software. Therefore, standalone algorithm performance is not applicable.
7. The Type of Ground Truth Used
The "ground truth" for the device's performance regarding safety and effectiveness was established by compliance with the international standard ISO 7785-2. This is an engineering/performance standard for dental handpieces.
8. The Sample Size for the Training Set
Not applicable. This is a hardware device, not an AI or machine learning model that requires a training set.
9. How the Ground Truth for the Training Set Was Established
Not applicable. As above, this is a hardware device and does not involve a training set as understood in the context of AI development.
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FEB 2 8 2013
- Owner/Company name, address a. NAKANISHI, INC. 700 Shimohinata, Kanuma-shi, Tochigi, 322-8666, Japan
b. Contact
Toshihiko Shinozaki Assistant Manager, R&D Department, Pharmaceutical Affairs Group NAKANISHI, INC. 700 Shimohinata, Kanuma-shi, Tochigi, 322-8666, Japan
| Phone: | 011-81-289-64-3380 |
|---|---|
| Fax: | 011-81-289-62-6665 |
| Email: | t-shinozaki@nsk-nakanishi.co.jp |
Application Correspondent C.
Fumiaki Kanai, Ph.D. President and CEO MIC International 4-1-17 Hongo, Bunkyo-ku Tokyo, 113-0033, Japan
Phone: 011-81-3-3818-8577 Fax: 011-81-3-3818-8573 Email: kanaif@mici.co.jp
d. Date prepared
June 28, 2012
e. Name of device
Trade Name: Classification Name: Regulation Name: Regulatory Class: Product Code:
TI-MAX Z45 Handpiece, Contra-and Right-angle Attachment, Dental Dental handpiece and accessories Class I EGS
510(k) Summary: Page 1 of 6
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Predicate devices ﮨﺖ
The Ti-MAX Z45 is substantially equivalent to the following legally marketed devices:
| 510(k): | K070663 |
|---|---|
| Trade name: | A-DEC/W&H SYNEA AIR-DRIVEN HIGHSPEED HANDPIECE, |
| MODELS TA-98, TA-97 | |
| A-DEC/W&H SYNEA HANDPIECE ATTACHMENT, MODELS WA-99LT, | |
| WA-86LT, WA-66LT, WA-56LT, HA-43LT | |
| Product code: | EFB |
| Classification Name: | Handpiece, Air-powered, Dental |
| 510(k): | K011061 |
| Trade name: | SURGICAL CONTRA-ANGLE HANDPIECES TYPES WS-56E, |
| WS-75-E/KM, WS-92E/3 | |
| Product code: | EGS |
Classification Name: Handpiece, Contra-and Right-angle Attachment, Dental
Hereinafter, the predicate devices are called "the SYNEA HANDPIECE (K070663)" and "the SURGICAL CONTRA-ANGLE HANDPIECES (K011061)", respectively, for convenience of discussion in this application. Regarding the SYNEA HANDPIECE (K070663), A-DEC/W&H SYNEA HANDPIECE ATTACHMENT is the exact predicate device for the TI-MAX Z45. Since the HA-43LT type of the A-DEC/W&H SYNEA HANDPIECE ATTACHMENT is a straight handpiece, the type is eliminated as the predicate device for the T1-MAX Z45 hereinafter in this submission. The SYNEA HANDPIECE (K070663) indicates A-DEC/W&H SYNEA HANDPIECE ATTACHMENT MODELS WA-99LT, WA-86LT, WA-66LT, WA-56LT in this application.
g. Description of the device
The Ti-MAX Z45 is a contra-angle dental handpiece which is powered by either an air-motor or electronic-micromotor for use in general dentistry. The TI-MAX Z45 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 Tr-MAX Z45 transmits rotational force from the motor to the gears through a clutch, and then the rotation force reaches the chuck and the dental bur receives the rotation force. The dental bur is able to cut and grind teeth and dentures using the rotation force.
h. Statement of Intended Use
TI-MAX Z45 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
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preparations, finishing and trimming teeth and filling materials, and removal of crowns and filling materials.
i. Summary of Technological Characteristics
Summary or receded in rotation of the TI-MAX Z45 is 168,000 min1. The rotation speed is increased by 4.2-fold at the chuck using the gears. Since the TI-MAX Z45 uses rotational force for the treatment, temperature increase may occur on the drilling point. Therefore, the TI-MAX Z45 has 4-port water spray outlet on the head in order to cool down the treatment area. It is possible to switch the type of coolant water flow, water jet or water spray. The TI-MAX Z45 has opticfiber for lighting.
The friction grip bur (not exceed 25 mm) which conforms ISO 1797-1 is intended to use for the TI-MAX Z45. The TI-MAX Z45 uses the push-button chuck mechanism.
The TI-MAX Z45 can be connected only E-type motors which conforms ISO 3964.
Statement of substantial equivalence i.
The Indications for Use of the TI-MAX Z45 is similar to the SYNEA HANDPIECE (K070663). The principle of operation of the TI-MAX Z45 is identical to the predicates. That is, the TI-MAX Z45 and the predicates transmit rotational force from the motor to the dental bur using the gears. The dental bur is able to cut and grind teeth and dentures using the rotation force. In addition, design features (Contra-Angle, Push-Button Chuck, Motor coupling, Thermal safety system) of the Ti-MAX Z45 are identical to those of the predicates.
Following table is comparison between the TI-MAX Z45 and the predicates.
| TI-MAX Z45 | SYNEA HANDPIECE(K070663) | SURGICALCONTRA-ANGLEHANDPIECES(K011061) | |
|---|---|---|---|
| Indications for Use | TI-MAX Z45 is poweredby either an air-motor orelectronic micromotorfor use in generaldentistry.The device is intendedfor cutting and grindingteeth, cavitypreparations, tooth andcrown preparations,finishing and trimming | The A-dec/W&H SyneaAir-Driven HighspeedHandpiece is anair-powered dentalhandpiece for use ingeneral dentistry. Thisdevice is designed forremoving cariousmaterial and excessfilling material, cavityand crown preparation,root canal preparations, | Indications are verywidespread in the fieldof implantology andsurgery. Thementioned handpieceshave been developedespecially for thefollowing applications:WS-56 E:for e,g.osteotomla on theupper and lower jaw.germectomls, |
| teeth and fillingmaterials, and removalof crowns and fillingmaterials. | finishing toothpreparations,restorations andpolishing teeth. | sequestrotomlaWS-75 E/KM: for e.g.implantology(preparation of thebone cavity, placingthe implants), surgicaltreatment ofdysgnathia,osteosynthesis,segmentosteotomlaand especially mildosteotomla.WS-92 E/3 : for e.g.hemisection, wisdomtooth extraction. | |
| Product Code | EGS | EFB | EGS |
| ClassificationName | Handpiece, Contra-andRight-angle Attachment,Dental | Handpiece, Air-powered,Dental | Handpiece, Contra-andRight-angleAttachment, Dental |
| Design features | Contra-Angle,Push-Button Chuck,Motor coupling,Thermal safety system | Contra-Angle,Push-Button Chuck,Motor coupling,Thermal safety system | Contra-Angle,Push-Button Chuck,Motor coupling,Thermal safety system |
| Gear ratio | 1:4.2 | 1:5, 1:1, 2:1, 10:1 | 1:1, 20:1. 1:2,7 |
| Maximummotor/drive speed | 40,000 rpm | 40,000 rpm | 50,000 rpm |
| Materials | Stainless Steel,Titanium | Unknown | Stainless steel |
| Motor coupling | Compliant with ISO3964 | Compliant with ISO3964 | Compliant with ISO3964 |
| Source of power | Air-motor,Electronic-micromotor | Air-motor,Electronic-micromotor | Air-motor,Electronic-micromotor |
| Light | Glass Rod (Fiberoptic) | With light type/Withoutlight type | With lighttype/Without light type |
| Dimension | Head Diameter: 9.6mmHead Height: 14.5mmLength: 96.2mm | Head Height: 12.3 mmor 13.7mm | Unknown |
| Weight | 66.5 g | Unknown | Unknown |
| Performance | Compliant with ISO7785-2 | Compliant with ISO7785-2 | Compliant with ISO7785-2 |
| -Eccentricity | 0.016 mm | Unknown | Unknown |
| -Force for burextraction | 25.3N | Unknown | Unknown |
| Sterilization | Sterilized by user(Autoclave) | Sterilized by user(Autoclave) | Sterilized by user(Autoclave) |
| Thermal safety | Air/Water spray,compliant withISO7785-2 | Air/Water spray,compliant withISO7785-2 | Air/Water spray,compliant withISO7785-2 |
| -Air/Water Sprayport | 4-port | Single or 5-port | Single or 3-port |
| -CoolantWaterType | Water spray/Water jet | Water spray | Water spray |
| -Flow Rate | More than 50 ml/min | More than 50 ml/min | More than 50 ml/min |
| -Waterpressuresetting range | 2 bar | 0.5-2 bar | Unknown |
| -Chip air pressuresetting range | 2 bar | 1.5-3bar | Unknown |
| Lubricant | PANA Spray (510(k)number is K052700) | W&H Service oil F1 | W&H Service oil F1 |
| Bur | FG burs | FG burs, contra-angleburs | FG burs, contra-angleburs |
| -Maximumburlength | 25 mm | 25mm (FG burs), 34mm(contra-angle burs) | 34mm (WS-56Econtra-angle burs), 45mm (WS-75 E/KM,contra-angle bur), 25mm (WS-92 E/3, FGbur) |
Comnarison table
510(k) Summary: Page 3 of 6
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510(k) Summary: Page 4 of 6
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Note*: The models for "the A-DEC/W&H SYNEA HANDPIECE ATTACHMENT" are used as the predicate device for the Ti-Max Z45 in the submission.
As shown in the comparison table, the indications for use of the TI-MAX Z45 is similar to the SYNEA HANDPIECE (K070663). As described above, the principle of operation and design features of the TI-MAX Z45 are identical to those of the predicates. However, the dimensions and materials of the TI-MAX Z45 are different from the predicates. The gear ratio of the TI-MAX Z45 is also different from that of the predicates. Therefore, the maximum rotation speed at the chuck is different between the Ti-MAX Z45 and the predicates. In addition, the number of the air/water spray port is different between the TI-MAX Z45 and the predicates. In order to evaluate that those differences do not affect safety and effectiveness of the TI-MAX Z45, bench testing was performed. Bench testing demonstrated that the TI-MAX Z45 met the requirement of ISO7785-2 which was used for evaluation of the predicate devices. Based on above result, the TI-MAX Z45 is substantially equivalent to the predicates and does not raise any new safety and effectiveness concern.
510(k) Summary: Page 5 of 6
Powerts: Partrers
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k. Bench Testing
The bench tests were performed in order to ensure the safety and effectiveness of the TI-MAX Z45, verify conformity to ISO 7785-2 and demonstrate substantial equivalence to the predicates.
All TI-MAX Z45 samples were compliant with ISO 7785-2 and demonstrated substantial equivalence to the predicates.
ﻨﺴﺘ Conclusion
The indications for use of the TI-MAX Z45 is similar to the SYNEA HANDPIECE (K070663). In addition, the principle of operation and design features of the TI-MAX Z45 are identical to those of the predicates. However, the dimensions and materials of the TI-MAX Z45 are different from the predicates. The gear ratio of the TI-MAX Z45 is also different from that of the predicates. Therefore, the maximum rotation speed at the chuck is different between the TI-MAX Z45 and the predicates. In addition, the number of the air/water spray port is different between the TI-MAX Z45 and the predicates. Although there are those differences in characteristics between the TI-MAX Z45 and the predicates, a number of performance testing indicated that the Ti-MAX Z45 met the requirement of the recognized consensus or voluntary standard. Based on above result, we conclude the TI-MAX Z45 is substantially equivalent to the predicates and does not raise any new safety and effectiveness concern.
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510(k) Summary: Page 6 of 6
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DEPARTMENT OF HEALTH & HUMAN SERVICES
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Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
February 28, 2013
Nakanishi, Incorporated C/O Fumiaki Kanai, Ph.D. President and Chief Executive Officer MIC International 4-1-17 Hongo, Bunkyo-ku Tokyo, Japan 113-0033
Re: K121901
Trade/Device Name: TI-MAX Z45 Regulation Number: 21 CFR 872.4200 Regulation Name: Dental Handpiece and Accessories Regulatory Class: I Product Code: EGS Dated: February 5, 2013 Received: February 11: 2013
Dear Dr. Kanai:
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, Orug 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. 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 contractlie ality 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 (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely vours.
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for
Anthony D. Watson, B.S., M.S., M.B.A. Director Division of Anesthesiology, General Hospital, Respiratory, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use
K121901 510(k) Number (If known):
Device Name: TI-MAX Z45
Indications for Use
TI-MAX Z45 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.
Prescription Use
(Per 21 CFR 801 Subpart D)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Mary S. Runner -S 013:02.28 07:38:56
(Division Sign-Off) Division of Anesthestology, General Hospital Infection Control, Dental Devices
510(k) Number;
§ 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.