(115 days)
Not Found
No
The description focuses on mechanical and material aspects of a dental handpiece and does not mention any AI or ML components or functionalities.
No.
The device is a dental handpiece used for cutting and drilling, which are procedural functions, not therapeutic functions as it does not directly treat a disease or condition.
No
Explanation: The device is described as an air-powered dental handpiece used for cutting and drilling, not for diagnosing conditions or diseases.
No
The device description clearly details a physical, air-powered dental handpiece made of stainless steel with a turbine, water spray, and chucking mechanism, indicating it is a hardware device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is "an air-powered dental handpiece for use in general dentistry." This describes a tool used directly on a patient's teeth and mouth for procedures like drilling or cutting.
- Device Description: The description details a mechanical device with an air-driven turbine, used with dental burrs and cutting instruments. It mentions features like water spray for cooling and a chucking mechanism for holding instruments.
- Lack of IVD Characteristics: IVD devices are used to examine specimens (like blood, urine, or tissue) outside of the body to provide information about a patient's health. The description of the CROMAX Turbine Handpiece does not involve any such specimen analysis.
Therefore, the CROMAX Turbine Handpiece is a dental instrument used for direct patient treatment, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The device is an air-powered dental handpiece for use in general dentistry.
Product codes
76 EFB
Device Description
The CROMAX Turbine Handpiece is an air-driven high-speed dental handpiece. It has an airdriven turbine with appropriate power and speed for use with dental carbide burrs and diamond cutting instruments. Construction is stainless steel for corrosion resistance. It has water spray for cooling of the cutting burr. One model has push-button chucking mechanism to grip cutting instrument with ISO standard shanks.
The CROMAX Turbine Handpiece may be sterilized by the steam autoclave method. The bearing are sealed.
Technically supported and adopted key components of rotor and ball bearing from Air, Switzerland. Foshion produced CROMAX turbine handpiece and powered by Bien -- ir.
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)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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
OCT 2 2 2004
Summary
510(k) Summary of safety and effectiveness
Date: 6/17/2004
| Submission By: | JR Medical Technologies, Inc.
6650 Cottage Hill Road, Suite 307
Mobile, AL 36695 |
|------------------------------|----------------------------------------------------------------------------------------------------------------------------------------|
| Manufactured by: | Shanghai Foshion Medical Instrument Co.,
Ltd.
Buld.15, NO. 1515 Yuandong Rd(N)
Fengxian District,
Shanghai 201401
China |
| Contact: | John Rhim
251-895-0303
251-479-7777 Fax
johnrhim@hotmail.com |
| Device Name: | CROMAX turbine handpiece |
| Common Name: | Handpiece, air-powered, dental |
| Classification Name: | Dental handpiece |
| Device Class: | Class I |
| Product Code: | 76 EFB |
| Code of Federal Regulations: | 21 CFR § 872.4200 |
| Indications for Use: | The device is an air-powered dental
handpiece for use in general dentistry. |
| Predicate Device Name: | T1 Line Dental Handpieces, K972436 and
Rapidd Highspeed Dental Handpiece
K003518 |
Description of Device:
The CROMAX Turbine Handpiece is an air-driven high-speed dental handpiece. It has an airdriven turbine with appropriate power and speed for use with dental carbide burrs and diamond cutting instruments. Construction is stainless steel for corrosion resistance. It has water spray for cooling of the cutting burr. One model has push-button chucking mechanism to grip cutting instrument with ISO standard shanks.
The CROMAX Turbine Handpiece may be sterilized by the steam autoclave method. The bearing are sealed.
Technically supported and adopted key components of rotor and ball bearing from § •››Air, Switzerland. Foshion produced CROMAX turbine handpiece and powered by Bien -- ir.
1
Substantially Equivalence - Safety and Effectiveness:
CROMAX Turbine Handpiece is substantially equivalent to one or are air-powered dental handpieces currently marketed in the USA. The handpiece is constructed of the same specifications as the predicate device to ensure biocompatibility. The handpiece conforms to applicable ISO standards.
2
Image /page/2/Picture/1 description: The image shows the seal of the U.S. Department of Health & Human Services. The seal features a stylized caduceus, a symbol often associated with medicine and healthcare, with three overlapping lines forming a wing-like shape. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the caduceus.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
OCT 2 2 2004
J.R. Medical Technologies, Incorporated C/O Mr. J. Harvey Knauss Contract Consultant Delphi Consulting Group 11874 South Evelyn Circle Houston, Texas 77071-3404
Re: K041755
Trade/Device Name: CROMAX Turbine Handpiece Regulation Number: 872.4200 Regulation Name: Dental Handpiece and Accessories Regulatory Class: I Product Code: EFB Dated: October 14, 2004 Received: October 18, 2004
Dear Mr. Knauss:
We have reviewed your Section 510(k) premarket notification of intent to market the device we have reviewed your becamined 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 Interstate commerce prior to fray are been reclassified in accordance with the provisions of Amendinens, or to active and Cosmetic Act (Act) that do not require approval of a premarket the Federal 1 600; Drag, Drag, therefore, market the device, subject to the general approvisions of the Act. The general controls provisions of the Act include controls provisions of the stration, 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 (1 Wry, It may be basyon 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 – Mr. Knauss
Please be advised that FDA's issuance of a substantial equivalence determination does not Please be advised that FDA S Issualled of a sacceantles with other requirements mean that FDA has made a decemination that your and ministered by other Federal agencies.
of the Act or any Federal statutes and regulations and real that and the registratio of the Act of any rederal statutes and registements, including, but not limited to: registration
You must comply with all the Act's requirements, including and manufacturing You must comply with an the Act 3 required interest 801); good manufacturing practice
and listing (21 CFR Part 807); labeling (21 CFR Part 801); gract 820'; and i and listing (21 CFR Part 807), laboring (21 CFR Part 820); and if
requirements as set forth in the quality systems (QS) regulation (21 CFR Part 821, 542 of the Ar requirements as set form in the quality systems (Sections 531-542 of the Act);
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) This letter will anow you to begin maticeming your alence of your device to an premarket nothleation. The I Dr Intellig of obserm.
Iegally 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), If you desire specific advice for your de recognize . Also, please note the regulation prease contact the Other of Other of Comphariet notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Illay obtain other general micromational and Consumer Assistance at its toll-free Division of Bircason or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html
Sincerely yours,
Qurs
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
Device Name: CROMAX Turbine Handpiece
Indications for Use: The device is an air-powered dental handpiece for use in general dentistry.
Prescription Use (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (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)
Sumana
(Division Sign-Off)
Division of Anesthesiology, General Hospital,
Continess Control Dental Devices Division of Anesthesionogy,
510(k) Number: