(50 days)
No
The summary describes a standard dental air-powered handpiece and makes no mention of AI or ML technology.
No.
The device is used for removing carious material, reducing hard tooth structure, cavity preparation, finishing tooth preparations and restorations, and polishing teeth, which are all mechanical procedures rather than therapeutic in nature (e.g., treating a disease or disorder).
No
The device is described as an "Air Turbine Handpiece" used for procedures like "removing carious material, reducing hard tooth structure, cavity preparation, finishing tooth preparations and restorations and polishing teeth." These are treatment or preparation functions, not diagnostic ones. There is no mention of the device being used to detect, identify, or analyze disease or conditions.
No
The device description explicitly states "Dental Air-Powered Handpiece," indicating a physical hardware device.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to examine specimens taken from the human body (like blood, urine, tissue) to provide information about a person's health. This information is used for diagnosis, monitoring, or screening.
- Device Function: The JINDELL High Speed Air Turbine Handpiece is a dental tool used directly on the patient's teeth for procedures like removing decay, shaping teeth, and polishing. It does not analyze specimens taken from the body.
- Intended Use: The stated intended use clearly describes procedures performed in the mouth on the patient, not laboratory analysis of samples.
Therefore, based on the provided information, the JINDELL High Speed Air Turbine Handpiece is a dental device used for direct treatment, not an In Vitro Diagnostic.
N/A
Intended Use / Indications for Use
The JINDELL High Speed Air Turbine Handpieces are intended for removing carious material, reducing hard tooth structure, cavity preparation, finishing tooth preparations and restorations and polishing teeth.
Product codes
EFB
Device Description
Not Found
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
licensed professionals
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 claim of substantial equivalence is based on comparisons of formulations and intended uses of the JINDELL High Speed Air Turbine Handpiece and its claimed predicate.
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
JINDELL
JINDELL MEDICAL INSTRUMENTS CO.,LTD
MEDICAL INSTRUME
5. 510(K) SUMMARY
JINDELL High Speed Air Turbine Handpiece Models: SW, SP, SU, ETU, MU
NOV - 2 2006
510K:
| Submitted by: | JINDELL MEDICAL INSTRUMENTS CO., LTD.
No. 6-1, Alley 51, Lane 607, Rueilong Rd., Cianjhen
Dist., 80642, Kaohsiung City, Taiwan, ROC |
|------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact person: | Dr. Jen, Ke-Min
No.58, Fu-Chiun Street, Hsin-Chu City,Taiwan, ROC
Tel: 886-3-5208829 fax: 886-3-5209783
E-mail: ceirs.jen@msa.hinet.net |
| Date Summary Prepared: | September 9, 2006 |
| Name of the Device: | Dental Air-Powered Handpiece |
| Classification: | Dental Air-Powered Handpiece ( class I medical
device; 21 CFR 872.4200 )
Product code: EFB
Panel: 72 |
| ● Predicate Device: | Dental Air-Powered Handpiece,
models: TIGER 100, TIGER 101, TIGER 200,
TIGER 201, TIGER 202
510K No -K052822 |
| ● Statement of Intended Use: | The JINDELL High Speed Air Turbine |
Handpieces are intended for removing carious material, reducing hard tooth structure, cavity preparation, finishing tooth preparations and restorations and polishing teeth.
CAUTION: Federal (US) law restricts the use of this device to licensed professionals.
1
Image /page/1/Picture/0 description: The image shows the logo and contact information for JINDELL MEDICAL INSTRUMENTS CO., LTD. The address is No.6-1, Alley 51, Lane 507, Ruilong Rd., Cianjhen District, Kaohsiung City 80642, Taiwan. The telephone number is +886-7-7221801, and the fax number is +886-7-724760. The email address is chinpao@seed.net.tw, and the website is http://www.taiwantrade.com.tw/inde.
- Performance Data: The claim of substantial equivalence is based on . comparisons of formulations and intended uses of the JINDELL High Speed Air Turbine Handpiece and its claimed predicate.
- Conclusion: Based on the information in the notification, JINDELL Medical ● Instruments Co., Ltd. believes that High Speed Air Turbine Handpieces are substantially equivalent to the claimed predicate, i.e., Dental Air-Powered Handpiece, models: TIGER 100, TIGER 101, TIGER 200, TIGER 201, TIGER 202, (K052822).
2
DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Jindell Medical Instruments Company, Limited C/O Dr. Ke-Min Jen ROC Chinese-European Industrial Research Society No.58, Fu-Chiun Street Hsin-Chu City China (TAIWAN) 30067
NOV - 2 2006
Re: K062740
Trade/Device Name: JINDELL High Speed Air Turbine Handpiece, Models: SW, SP, SU, ETU, MU Regulation Number: 872.4200 Regulation Name: Dental Handpiece and Accessories Regulatory Class: I Product Code: EFB Dated: September 9, 2006 Received: September 13, 2006
Dear Dr. Jen:
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.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such 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 - Dr. Jen
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); 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.
This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at (240) 276-0115. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours.
Chiu Lin, Ph.D.
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 ( If Known ):
Device Name: JJNDELL High Speed Air Turbine Handpiece,
Models: SW, SP, SU, ETU, MU
Indications for Use :
- JINDELL High Speed Air Turbine Handpiece, models: SW, SP, SU, ETU, MU are intended for removing carious material, reducing hard tooth structure, cavity preparation, finishing tooth preparations and restorations and polishing teeth.
- · JINDELL High Speed Air Turbine Handpiece carries the following label:
CAUTION: Federal (US) law restricts the use of this device to licensed professionals.
Prescription Use
AND/OR
Over-The-Counter Use
(Part 21 CFR 801 Subpart D)
(21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Suxes Garne
Anesthesiology, General Hospal,
An Control, Dental Devices
Lark062740
ber
P5
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