(341 days)
Not Found
No
The summary describes a mechanical dental handpiece and does not mention any software, algorithms, or data processing that would indicate the use of AI or ML.
No
The device is described as a "surgical tool" for dental procedures, which implies intervention to treat a condition rather than diagnose or prevent, qualifying it as a therapeutic device.
No
The device is described as a surgical tool used for impacted third molar removal and periodontal procedures, which are treatment functions, not diagnostic ones.
No
The device description clearly states it is an air-powered dental handpiece, which is a physical hardware device, not software.
Based on the provided information, the Ti-Max X450 is not an IVD (In Vitro Diagnostic) device.
Here's why:
- Intended Use: The intended use is described as a "surgical tool for impacted third molar removal and periodontal procedures." This is a direct surgical intervention on a patient, not a test performed on a sample taken from the body to diagnose a condition.
- Device Description: The description details a high-speed dental handpiece used for mechanical procedures. This aligns with a surgical tool, not a diagnostic device.
- Lack of IVD characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), detecting markers, or providing diagnostic information based on laboratory testing.
IVD devices are specifically designed to perform tests on samples taken from the human body to provide information for the diagnosis, monitoring, or treatment of diseases or conditions. The Ti-Max X450's function is purely mechanical and surgical.
N/A
Intended Use / Indications for Use
The Ti-Max X450 is an air-powered dental handpiece with intended use of being a surgical tool for impacted third molar removal and periodontal procedures for which a conventional handpiece would be used.
The. Ti-Max X450 is intended for use with a friction grip bur that conforms to ISO 1797-1 standard. Recommended supply air pressure is between 0.22 and 0.30 MPa, which results in high-speed bur rotation (approximately 380,000 to 450,000 RPM).
Product codes
EFB
Device Description
The Ti-Max X450 air-powered high-speed dental handpiece capable of reaching rotational speeds of 380,000 to 450,000 revolutions per minute. The device includes non-optic, fiber-optic, and LED models. All models have a 45 degree back angle. 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
Not Found
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
The Ti-Max X450 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
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
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 for NSK, which is a Japanese manufacturer of bearings. The logo is in white text on a black background. The letters are bold and sans-serif. The logo is simple and easy to read.
5. 510(k) SUMMARY
| Submitter: | Nakanishi, Inc.
700 Shimohinata
Kanuma-Shi, Tochigi-Ken Japan 322-8666
JUN 20 2012 |
|-------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person: | Mr. Toshihiko Shinozaki
Assistant Manager, Technical Affairs Department
TEL: 0289(62)6011
FAX: 0289(62)6665
t-shinozaki@nsk-nakanishi.co.jp |
| Date Prepared: | July 7, 2011 (Revised June 18, 2012) |
| Trade Name: | Ti-Max X450 |
| Common Name: | High Speed Air Turbine Handpiece |
| Classification Name: | EFB 872.4200 Handpiece, Air-Powered, Dental |
| Predicate Device: | K952927 - Palisades Dental, Impact Air 45 Handpiece
K101717 - Aerobine, Inc., Air Powered Dental Handpiece [Karam45, Dexor45] |
| Device Description: | The Ti-Max X450 air-powered high-speed dental handpiece capable of reaching
rotational speeds of 380,000 to 450,000 revolutions per minute. The device includes
non-optic, fiber-optic, and LED models. All models have a 45 degree back angle.
Models are available to connect directly to the couplings of specific brands. |
| Statement of
Intended Use: | The Ti-Max X450 is an air-powered dental handpiece with intended use of being a
surgical tool for impacted third molar removal and periodontal procedures for
which a conventional handpiece would be used. |
| | The Ti-Max X450 is intended for use with a friction grip bur that conforms to ISO
1797-1 standard. Recommended supply air pressure is between 0.22 and 0.30 MPa,
which results in high-speed bur rotation (approximately 380,000 to 450,000 RPM). |
| Summary of
Technological
Characteristics: | The Ti-Max X450 is capable of achieving high-speed rotation of 380,000 to
450,000 revolutions per minute when provided with a supply air pressure of 0.22 to
0.30 MPa (32 - 44 psi). This provides a torque of at least 0.09Ncm, while
generating a noise level of 80dBA or less. The Ti-Max X450 has a 45 degree back
angle. 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 X450 has a one-touch quick connect coupling system. The Ti-Max
X450 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 X450 has models available that are designed to connect
directly to the couplings of other brands. |
NAKANISHI INC.
www.nsk-inc.com
ﺎ.
.
Section 5: Page 1 of 2 Headquarters : 700 Shimohihata Kanuma-shi Tochigi 322-8666, Japan Tokyo Office : MY Building 1-13-3 Ueno Taito-ku Tokyo 110-0005, Japan
·
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11:33:33
KIJDO24
1
The Ti-Max X450 was developed and is produced under consideration of all Performance applicable technical standards, internal specifications, and FDA guidance Testing: documents. The product's conformance with applicable international and internal standards was verified in the course of bench testing. Nakanishi considers the Ti-Max X450 to be substantially equivalent to the predicate Conclusion:
devices listed above. This conclusion is based on the similarities in intended use, principles of operation, functional design, and established medical use, and demonstrates that the Ti-Max X450 is substantially equivalent to the declared predicate devices.
Image /page/1/Picture/2 description: The image shows a black and white drawing of a bird. The bird is in flight, with its wings spread and its head turned to the side. The bird's feathers are detailed, and its beak is slightly open. The background is plain, with some text at the bottom of the image.
2
DEPARTMENT OF HEALTH & HUMAN SERVICES
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 circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the circumference. Inside the circle is a stylized image of an eagle, with its wings spread and its head turned to the right.
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
JUN 2 0 2012
Nakanishi, Incorporated C/O Ms. Diane Rutherford Regulatory Engineer Ken Block Consulting 1201 Richardson Drive, Suite 280 Richardson, Texas 75080
Re: K112024
Trade/Device Name: Ti-Max X450 Regulation Number: 21 CFR 872.4200 Regulation Name: Dental Handpiece and Accessories Regulatory Class: I Product Code: EFB Dated: June 4, 2012 Received: June 12, 2012
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- 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:
Device Name: Ti-Max X450
Indications for Use:
. .
.
The Ti-Max X450 is an air-powered dental handpiece with intended use of being a surgical tool for impacted third molar removal and periodontal procedures for which a conventional handpiece would be used.
The. Ti-Max X450 is intended for use with a friction grip bur that conforms to ISO 1797-1 standard. Recommended supply air pressure is between 0.22 and 0.30 MPa, which results in high-speed bur rotation (approximately 380,000 to 450,000 RPM).
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
510(k) Number:
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