(216 days)
Not Found
No
The device description and performance studies focus on mechanical and optical properties of a dental handpiece, with no mention of AI or ML.
No
The device is a dental abrasive tool used for preparing teeth, not for treating or curing a disease or condition.
No
The device is described as an abrasive tool used for material removal and preparation, not for identifying pathologies or conditions.
No
The device description clearly details a physical, mechanical device (dental handpiece) with various hardware components (air turbine, cooling system, head types, optic light guide, coupling). It is not solely software.
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, polishing, etc.). This is a direct intervention on the patient's anatomy.
- Device Description: The description details a high-speed rotating dental tool. This is a physical instrument used in a dental procedure.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens derived from the human body to provide information for diagnostic purposes. IVDs typically involve analyzing blood, urine, tissue, or other bodily fluids or samples.
This device is a dental instrument used for treatment and preparation, not for in vitro diagnostic testing.
N/A
Intended Use / Indications for Use
High Speed Air Turbine Handpiece is intended for removing carious material, excess filling material, cavity and crown preparation, finishing tooth preparations, root canal preparations and polishing teeth.
Product codes (comma separated list FDA assigned to the subject device)
EFB
Device Description
The proposed devices, High Speed Air Turbine Handpiece, is a dental abrasive device that rotates at high speed air as the driving force. It has 11 models: G100, G200, G300, G400, G450, G500, G600, G700, G700L, G800 and G800L.
The proposed device has the following features
The cooling system includes air/water spray or only water spray. .
The head types include standard head and miniature head.
The angle of the head and shaft include 45℃ and 90°. In general, dentist usually uses 90° handpiece having teeth treatment. Except for wisdom teeth 45°handpieces is considered more desirable for wisdom teeth operation .It is because the 45° angle is more appropriate for the angle of eruption of wisdom teeth.
High Speed Handpieces are able to run from 320,000rmp to 430,000rmp. G450, G700L and G800L have optic light guide for light function, other models don't have the optic light guide. Coupling is the accessory for the some models of the proposed handpiece to connect with tubes of dental unit. G500 and G600 require additional 4-hole coupling, and the 4-hole coupling is included in the product package. G450,G700, G800 and G800. require additional quick coupling is not included in the product package. The user shall purchase the compatible coupler for G450,G700, G700L, G800 and G800L.
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
The proposed device, High Speed Air Turbine Handpiece, is tested per tISO 14457-2017 Dentistry - Handpieces and motors, to evaluate the handpiece's following particular performance. Noise level @ Background noise level 56 dB(A) Flow rate of air supply @ 400kPa Flow rate of spray air @ 200kPa(2.0 bar) Flow rate of water supply @200kPa(2.0 bar) The force required to extract the test mandrels from the chuck system for Type 5 test mandrels Torque @ Type 5 test mandrels Speed of handpiece @0.22MPa Dynamic eccentricity Stall torque The light at the output side of the handpiece.
The clinical testing is not applicable.
The conclusions drawn from the nonstrate that the proposed device is as safe, as effective, and performs as well as the legally marketed predicate device K152146.
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
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.
April 30, 2024
Litu Tech Ltd. % Diana Hong General Manager Mid-Link Consulting Co. Ltd. P.O. Box 120-119 Shanghai, 200120 CHINA
Re: K233122
Trade/Device Name: High Speed Air Turbine Handpiece (G100,G200,G300,G400,G450,G500,G600,G700,G700L,G800,G800L) Regulation Number: 21 CFR 872.4200 Regulation Name: Dental Handpiece And Accessories Regulatory Class: Class I, reserved Product Code: EFB Dated: March 29, 2024 Received: March 29, 2024
Dear Diana Hong:
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 (the 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 available 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
Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).
Your device is also subject to, among other requirements, the Quality System (OS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30, Design controls; 21 CFR 820.90, Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).
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 Part 803) for devices or postmarketing safety reporting (21 CFR Part 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 Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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).
2
Sincerely,
Michael E. Adjodha -S
Michael Adjodha, MChE, RAC, CQIA 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
3
Indications for Use
Form Approved: OMB No. 0910-0120 Expiration Date: 06/30/2023 See PRA Statement below.
Submission Number (if known)
Device Name
High Speed Air Turbine Handpiece
(G100,G200,G300,G400,G450,G500,G600,G700,G700L,G800,G800L)
Indications for Use (Describe)
High Speed Air Turbine Handpiece is intended for removing carious material, excess filling material, cavity and crown preparation, finishing tooth preparations, root canal preparations and polishing teeth.
Type of Use (Select one or both, as applicable)
Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
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DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
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4
510(k) Summary
Prepared on: 2023-09-27
Contact Details
21 CFR 807.92(a)(1)
| Applicant Name | Litu Tech Ltd. | |||
|---|---|---|---|---|
| Applicant Address | C1-2 No. 12 Denengxi Road Torch Zone, Zhongshan, Guangdong, China | |||
| Guangdong 528437 China | ||||
| Applicant Contact Telephone | +86-760-8697442 | |||
| Applicant Contact | Mr. Guangzhao Liu | |||
| Applicant Contact Email | info@litutechltd.com | |||
| Correspondent Name | Mid-Link Consulting Co., Ltd. | |||
| Correspondent Address | P.O. Box 120-119 Shanghai 200120 China | |||
| Correspondent Contact Telephone | 86-21-2281-5850 | |||
| Correspondent Contact | Diana Hong | |||
| Correspondent Contact Email | info@mid-link.net | |||
| Device Name | ||||
| 21 CFR 807.92(a)(2) | ||||
| Device Trade Name | High Speed Air Turbine Handpiece | |||
| (G100,G200,G300,G400,G450,G500,G600,G700,G700L,G800,G800L) | ||||
| Common Name | Dental handpiece and accessories | |||
| Classification Name | Handpiece, Air-Powered, Dental | |||
| Regulation Number | 872.4200 | |||
| Product Code | EFB | |||
| Legally Marketed Predicate Devices | ||||
| 21 CFR 807.92(a)(3) | ||||
| Predicate # | Predicate Trade Name (Primary Predicate is listed first) | Product Code | ||
| K152146 | High Speed Handpieces and Accessories | EFB | ||
| Device Description Summary | 21 CFR 807.92(a)(4) |
The proposed devices, High Speed Air Turbine Handpiece, is a dental abrasive device that rotates at high speed air as the driving force. It has 11 models: G100, G200, G300, G400, G450, G500, G600, G700, G700L, G800 and G800L.
The proposed device has the following features
The cooling system includes air/water spray or only water spray. .
The head types include standard head and miniature head.
The angle of the head and shaft include 45℃ and 90°. In general, dentist usually uses 90° handpiece having teeth treatment. Except for wisdom teeth 45°handpieces is considered more desirable for wisdom teeth operation .It is because the 45° angle is more appropriate for the angle of eruption of wisdom teeth.
5
High Speed Handpieces are able to run from 320,000rmp to 430,000rmp. G450, G700L and G800L have optic light guide for light function, other models don't have the optic light guide. Coupling is the accessory for the some models of the proposed handpiece to connect with tubes of dental unit. G500 and G600 require additional 4-hole coupling, and the 4-hole coupling is included in the product package. G450,G700, G800 and G800. require additional quick coupling is not included in the product package. The user shall purchase the compatible
Intended Use/Indications for Use
coupler for G450,G700, G700L, G800 and G800L.
High Speed Air Turbine Handpiece is intended for removing carious material, cavity and crown preparation, finishing tooth preparations and restorations, root canal preparations and polishing teeth.
Indications for Use Comparison
The proposed device and predicate device have the same indications for use.
Technological Comparison
The proposed device and predicate device have the same principles of operation, type of chuck, head angle. Both they have cooling system, and some models of them have the fiber optics. Regarding the technological characteristics, there are difference on Light intensity, Speed in rpms and Bur retention the performance test has conducted on the proposed device based on ISO 14457:2017, and the test result demonstrated that the proposed device complies with the standard requirements, the differences on technological characteristics do not affect the safety and effectiveness of the proposed device.
Non-Clinical and/or Clinical Tests Summary & Conclusions 21 CFR 807.92(b)
The proposed device, High Speed Air Turbine Handpiece, is tested per tISO 14457-2017 Dentistry - Handpieces and motors, to evaluate the handpiece's following particular performance. Noise level @ Background noise level 56 dB(A) Flow rate of air supply @ 400kPa Flow rate of spray air @ 200kPa(2.0 bar) Flow rate of water supply @200kPa(2.0 bar) The force required to extract the test mandrels from the chuck system for Type 5 test mandrels Torque @ Type 5 test mandrels Speed of handpiece @0.22MPa Dynamic eccentricity Stall torque The light at the output side of the handpiece
The clinical testing is not applicable.
The conclusions drawn from the nonstrate that the proposed device is as safe, as effective, and performs as well as the legally marketed predicate device K152146.
21 CFR 807.92(a)(6)
21 CFR 807 92(a)(5)
21 CFR 807 92(a)(5)