(84 days)
Not Found
No
The description focuses on the mechanical aspects of a dental handpiece and does not mention any AI or ML capabilities.
Yes
The handpiece is intended for removing carious material, reducing hard tooth structure, cavity preparation, finishing tooth preparations and restorations, and polishing teeth, which are all therapeutic dental procedures.
No.
The device is described as an air-powered dental handpiece used for procedures like removing carious material, reducing hard structures, cavity preparation, finishing, and polishing teeth. These are all therapeutic or procedural actions, not diagnostic ones.
No
The device description clearly states it is an "air-powered high-speed dental handpiece" and includes physical components like turbines and different models (non-optic, fiber-optic, LED), indicating it is a hardware device, 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 describes a device used for mechanical procedures on teeth (removing material, preparing cavities, finishing, polishing). This is a direct intervention on the patient's body.
- Device Description: The description confirms it's an air-powered dental handpiece, a tool for physical manipulation.
- Lack of IVD Characteristics: IVD devices are used to examine specimens (like blood, urine, tissue) outside the body to provide information about a person's health. This device does not involve the analysis of any biological specimens.
The device is a dental handpiece, which is a medical device used for treatment and procedures performed directly on the patient.
N/A
Intended Use / Indications for Use
The Ti-Max X Turbine Series is an air-powered dental handpiece intended for removing carious material, reducing hard tooth structure, cavity preparation, finishing tooth preparations and restorations and polishing teeth.
Product codes (comma separated list FDA assigned to the subject device)
EFB
Device Description
The Ti-Max X Turbine is an air-powered high-speed dental handpiece capable of reaching rotational speeds of 300,000 to 450,000 revolutions per minute. The device includes non-optic, fiber-optic, and LED models. Models are available to connect directly to the couplings of specific brands.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
tooth
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
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 Ti-Max X Turbine was developed and is produced under consideration of all applicable technical standards, internal specifications, and FDA guidance documents. The product's conformance with applicable international and internal standards was verified in the course of bench testing.
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.
Not Found
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
MAR - 5 2012
。
関連項目
5. 510(k) SUMMARY
. . ...
| Submitter: | Nakanishi, Inc.
700 Shimohinata
Kanuma-Shi, Tochigi-Ken Japan 322-8666 |
|-------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person: | Mr. Toshihiko Shinozaki
Assistant Manager, R&D Dept. Pharmaceutical Affairs Gr.
TEL: +81-0289-64-3380
FAX: 0289(62)6665
t-shinozaki@nsk-nakanishi.co.jp |
| Date Prepared: | December 1, 2011 |
| Trade Name: | Ti-Max X Turbine |
| Common Name: | High Speed Air Turbine Handpiece |
| Classification Name: | 872.4200 EFB Handpiece, Air-Powered, Dental |
| Predicate Device: | K102517 - Thunder Tiger, Inc., Tiger 500 Series High Speed Handpieces and
Attachment |
| Device Description: | The Ti-Max X Turbine is an air-powered high-speed dental handpiece capable of
reaching rotational speeds of 300,000 to 450,000 revolutions per minute. The device
includes non-optic, fiber-optic, and LED models. Models are available to connect
directly to the couplings of specific brands. |
| Statement of
Intended Use: | The Ti-Max X Turbine is an air-powered dental handpiece intended for removing
carious material, reducing hard tooth structure, cavity preparation, finishing tooth
preparations and restorations and polishing teeth. |
| Summary of
Technological
Characteristics: | The Ti-Max X Turbine is intended for use with a friction grip bur that conforms to
ISO 1797-1 standard. Recommended supply air pressure is between 0.25 and 0.30
MPa, which results in high-speed bur rotation.
The Ti-Max X Turbine is capable of achieving high-speed rotation of 300,000 to
450,000 revolutions per minute when provided with a supply air pressure of 0.25 to
0.30 MPa (36 - 44 psi). This provides a torque of at least 0.05Ncm, while
generating a noise level of 80dBA or less. Also available are models with fiber
optic or LED lighting. All models include a water jet that is directed to the bur
point.
The Ti-Max X Turbine has a one-touch quick connect coupling system. The Ti-Max
X Turbine can connect directly to the dental unit, or a swivel adapter can be used.
Direct connection can be made with 4- and 5-hole connections that meet ISO 9168
specifications. A swivel adapter is connected between the handpiece and hose in the
case of 4-, 3-, and 2-hole connections, also in compliance with ISO 9168, type 2. In
addition, the Ti-Max X Turbine has models available that are designed to connect
directly to the couplings of other brands. |
Section 5: Page 1 of 2
1
Performance Testing:
The Ti-Max X Turbine was developed and is produced under consideration of all applicable technical standards, internal specifications, and FDA guidance documents. The product's conformance with applicable international and internal standards was verified in the course of bench testing.
Conclusion:
Nakanishi considers the Ti-Max X Turbine to be substantially equivalent to the predicate device listed above. This conclusion is based on the similarities in intended use, principles of operation, functional design, and established medical use, and does not raise new issues of safety and effectiveness.
Image /page/1/Picture/4 description: The image shows a black and white drawing of a bird in flight. The bird has long, pointed wings and a long tail. The bird's body is slender, and its head is small. The bird is flying against a white background. The image is simple and elegant.
Section 5: Page 2 of 2
Headquarters : 700 Shimohihata Kanuma-shi Tochigi 322-8666, Japan NAKANISHI INC. Tokyo Office : MY Building 1-13-3 Ueno Taito-ku Tokyo 110-0005, Japan www.nsk-inc.com
2
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three stripes representing the agency's mission to promote health, well-being, and human services. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the eagle symbol.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
Nakanishi. Inc. C/O Ms. Diane Rutherford Regulatory Engineer Ken Block Consulting 1201 Richardson Drive, Suite 280 Richardson, Texas 75080
MAR - 5 2012
Re: K113655
Trade/Device Name: Ti-Max X Turbine Regulation Number: 21 CFR 872.4200 Regulation Name: Dental Handpiece and Accessories Regulatory Class: I Product Code: EFB Dated: December 1, 2011 Received: December 12, 2011
Dear Ms. Rutherford:
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. 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.
3
Page 2 - Ms. Rutherford
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/Resourcesfor You/Industry/default.htm.
Sincerely yours,
Nh for
Anthony D. Watson, B.S., M.S., M.B.A. Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
INDICATIONS FOR USE
510(k) Number: K113655
Device Name: Ti-Max X Turbine
Indications for Use:
The Ti-Max X Turbine Series is an air-powered dental handpiece intended for removing carious material, reducing hard tooth structure, cavity preparation, finishing tooth preparations and restorations and polishing teeth.
Prescription Use X
(21 CFR 801 Subpart D)
AND/OR Over-the-Counter Use _ _
(21 CFR 801 Subpart:C)
(PLEASE DO NOT WRITE BELOW THIS LINE – CONTINUE ON ANOTHER PAGE IF NEEDED)--
Concurrence of CDHR, Office of Device Evaluation (ODE)
(Division Sign-Off)
Division of Anesthesiology, General Hospital
Infection Control, Dental Devices
| Labels | Values |
|---|---|
| 510(k) Number: | K113658 |
Page 1 of 1