(90 days)
Not Found
Not Found
No
The summary describes a mechanical dental handpiece and turbine with features for bur changing and lubrication, with no mention of AI or ML.
No.
The device description indicates it is a high-speed dental handpiece used for drilling and preparation of dental caries, which is a tool for a procedure rather than for therapy itself.
No
Explanation: The device is a dental handpiece used for drilling and preparing dental caries for restoration. Its function is procedural (drilling/preparation) rather than for diagnosing conditions.
No
The device description clearly states it is a "Lube Free Autochuck Turbine with Vortex Air Seal for use with StarDental 430 Series Lube Free High Speed Dental Handpiece." This describes a physical component (a turbine) that is part of a dental handpiece, which is a hardware device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device Function: The description clearly states the device is a high-speed dental handpiece used intraorally for drilling and preparing dental caries. This is a mechanical tool used directly on the patient's body for a therapeutic/restorative purpose.
- Lack of Biological Sample Analysis: There is no mention of the device analyzing any biological samples or providing diagnostic information based on such analysis.
Therefore, this device falls under the category of a medical device used for treatment/procedure, not an in vitro diagnostic.
N/A
Intended Use / Indications for Use
High-speed dental handpieces are used intraorally by trained dental professionals for drilling and preparation of dental caries for restoration, such as fillings. The intended use is identical to that of the predicate StarDental 430 Series Lube Free High Speed Handpiece. Autochuck turbines are used in place of a bur tool to facilitate bur changing. The intended use of the StarDental Autochuck Turbine with Vortex Air Seal is to both provide the convenience of tool-free bur changing and to eliminate the necessity of lubrication of the turbine after use and before sterlization.
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
intraorally
Indicated Patient Age Range
Not Found
Intended User / Care Setting
trained dental 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 (study type, sample size, AUC, MRMC, standalone performance, key results)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
StarDental 430 Series High Speed Handpiece
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
K98 2593
0CT 2 2 1998 Lube Free Autochuck Turbine with Vortex Air Seal for use with StarDental 430 Series Lube Free High Speed Dental Handpiece
510(k) Summary
Company:
StarDental, Division of DentalEZ Group Owner/operator number 2520265
Contact Person:
Keith C. Peithmar , Director of Marketing StarDental, Division of DentalEZ Group 1816 Colonial Village Lane Lancaster, PA 176301 Phone: (717) 291-1161 (717) 29' -9742 Fax:
Device Trade Name:
Lybe Free Autochuck Turbine with Vortex Air Seal for use with StarDental 430 Series Lube Free High Speed Dental Handpiece
Dental Handpiece and Accessories Common or Usual Name StarDental 430 Series High Speed Handpiece Predicate Device:
Intended Use/Description:
High-speed dents I handpieces are used intraorally by trained dental professionals for drilling and preparation of dental caries for restoration, such as fillings. The intended use is identical to that of the predicate StarDental 430 Series Lube Free High Speed Handpiece. Autochuck turbines are used in place of a bur tool to facilitate bur changing. The intended use of the StarDental Autochuck Turbine with Vortex Air Seal is to both provide the convenience of tool-free bur changing and to eliminate the necessity of lubrication of the turbine after use and before sterlization.
Substantial Equivalence:
The determination of substantial equivalence is based on the fact that the proposed StarDental device and the predicate StarDental device utilize substantially equivalent intended use, technology, design, manufacturing, and materials and so will be substantially equ valent in clinical performance.
1
Image /page/1/Picture/2 description: The image is a black and white logo for the U.S. Department of Health and Human Services. The logo features the department's emblem, which consists of a stylized caduceus-like symbol with three abstract human figures. The emblem is encircled by the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" in a circular arrangement. The text is in all capital letters and is evenly spaced around the emblem.
OCT 22 1998
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Mr. Keith C. Peithman Director of Marketing StarDental, Division of DentalEZ Group 1816 Colonial Village Lane Lancaster, Pennsylvania 17601
Re : K982593 Trade Name: Lube Free Autochuck Turbine with Vortex Air Seal for Use with StarDental 430 Series Lube Free High Speed Dental Handpiece Regulatory Class: I Product Code: EFB Dated: July 21, 1998 Received: July 24, 1998
Dear Mr. Peithman:
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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, Druq, and Cosmetic Act (Act). You may, therefore, market the device, subject to the general controls provisions The general controls provisions of the Act of the Act. include requirements for annual registration, listing of devices, qood manufacturing practice, labeling, and prohibitions aqainst misbranding and adulteration.
If your device is classified (see above) into either class II (Special Controls) or class III (Premarket Approval), 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 895. A substantially equivalent determination assumes compliance with the Good Manufacturing Practice for Medical Devices: General (GMP) regulation (21 CFR Part 820) and that, through periodic GMP inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP requlation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.
2
Page 2 - Mr. Peithman
This letter will allow you to begin marketing your device as described in your 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 requlation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4692. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to
premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".
Sincerely yours,
Patricia Cuenito flor
Timothy A. Ulatowski Director Division of Dental, Infection Control, and General Hospital Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
3
Statement of Indications of Use
High-speed dental handpieces are used intraorally by trained dental professionals for drilling and preparation of dental caries for restoration, such as fillings. The intended use is identical to that of the predicate 430 Series Lube Free High Speed Handpiece.
Autochuck turbines are used in place of a bur tool to facilitate bur changing,
The intended use of the Star Autochuck Turbine with Vortex Air Seal is to both provide the convenient:e of tool-free bur changing and to eliminate the necessity of lubrication of the turbin a after use and before sterilization.
Prescription Use
per 21 CFR 801,109
Heald Shipman
(Division Sign-Off) Division of Demal, Infection Control, and General Hospital Devices 510(k) Number _