LUBE FREE AUTOCHUCK TURBINE WITH VORTEX AIR SEAL FOR USE WITH STAR DENTAL 430 SERIES LUBE FREE HIGH SPEED DENTAL HANDPIE

K982593 · Dentalez Group · EFB · Oct 22, 1998 · Dental

Device Facts

• Record ID: K982593
• Device Name: LUBE FREE AUTOCHUCK TURBINE WITH VORTEX AIR SEAL FOR USE WITH STAR DENTAL 430 SERIES LUBE FREE HIGH SPEED DENTAL HANDPIE
• Applicant: Dentalez Group
• Product Code: EFB · Dental
• Decision Date: Oct 22, 1998
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.4200
• Device Class: Class 1

Intended 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 convenience of tool-free bur changing and to eliminate the necessity of lubrication of the turbine after use and before sterilization.

Device Story

The Lube Free Autochuck Turbine with Vortex Air Seal is a replacement turbine component for the StarDental 430 Series high-speed dental handpiece. It functions as a mechanical assembly that enables tool-free bur changing via an autochuck mechanism and incorporates a vortex air seal to eliminate the need for turbine lubrication prior to sterilization. The device is used by dental professionals in a clinical setting to facilitate dental restorative procedures. By removing the requirement for manual lubrication, the device simplifies maintenance workflows and ensures the handpiece is ready for sterilization, potentially increasing operational efficiency for the clinician.

Clinical Evidence

No clinical data provided; substantial equivalence is based on design and technological similarities to the predicate device.

Technological Characteristics

Mechanical turbine assembly for high-speed dental handpieces. Features an autochuck mechanism for tool-free bur retention and a vortex air seal design to enable lube-free operation. Designed for integration into existing StarDental 430 Series handpiece housings.

Indications for Use

Indicated for use by trained dental professionals for intraoral drilling and preparation of dental caries for restoration, such as fillings.

Regulatory Classification

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.

Predicate Devices

• StarDental 430 Series Lube Free High Speed Handpiece

Submission Summary (Full Text)

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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: [phone] (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.

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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.

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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 [phone]. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. 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 [phone] or [phone] 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

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## 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 _