STARDENTAL TITAN 3 LUBEFREE MOTOR ATTACHMENTS

K983574 · Dentalez Group · EGS · Jan 8, 1999 · Dental

Device Facts

• Record ID: K983574
• Device Name: STARDENTAL TITAN 3 LUBEFREE MOTOR ATTACHMENTS
• Applicant: Dentalez Group
• Product Code: EGS · Dental
• Decision Date: Jan 8, 1999
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.4200
• Device Class: Class 1
• Attributes: Therapeutic

Intended Use

Low speed dental attachments are used intraorally by trained dental professionals for drilling and preparation of dental cavities for restoration, such as fillings. Furthermore, the intended use extends to disking, cavity and crown preps, polishing, post and pin drilling and pin setting. The intended use is identical to that of the predicate low speed motor attachments.

Device Story

StarDental TITAN Series Motor Attachments are dental accessories designed for use with low-speed dental motors. The device functions as a mechanical interface between the motor and dental burs or tools. Compressed air powers a variable speed rotary vane motor, which transmits torque through a geared drive train to the attachment. The primary innovation is the use of non-lubricated bearings and bushings, replacing traditional lubricated components. The device is operated by dental clinicians in a clinical setting to perform routine restorative procedures such as cavity preparation, polishing, and pin setting. The output is mechanical rotation, which allows the clinician to perform precise dental work, directly facilitating restorative treatment and improving patient oral health outcomes.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Mechanical dental attachment; non-lubricated bearings and bushings; geared drive train; powered by compressed air via variable speed rotary vane motor.

Indications for Use

Indicated for use by trained dental professionals for intraoral procedures including drilling, cavity preparation, disking, crown preparation, polishing, post and pin drilling, and pin setting.

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

• Star (low speed motor attachments)
• Midwest (low speed motor attachments)
• KAVO (low speed motor attachments)
• W&H (low speed motor attachments)
• NSK (low speed motor attachments)
• Champion Dental (low speed motor attachments)

Submission Summary (Full Text)

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K98 3574

# 510(k) SUMMARY StarDental® LUBE FREE LOW SPEED MOTOR ATTACHMENTS

#### Company:

StarDental® . Division of DentalEZ® Owner/operator number 2520265

#### Contact Person:

William Guscott Product Development Engineer StarDental®, Division of DentalEZ® 1816 Colonial Village Lane Lancaster, PA 17601 Phone: [phone] Fax: [phone]

## Device Trade Name:

StarDental® TITAN® Series Motor Attachments

## Common or Usual Name:

Low Speed Motor Attachments

#### Predicate Devices:

Star, Midwest, KAVO, W&H, NSK and Champion Dental low speed motor attachments.

#### Description/Intended Use:

Dental attachments and accessories to be used by the dental clinician during routine dental procedures. The attachments affix to a low speed dental motor.

#### Substantial Equivalence:

The Low Speed Attachments as submitted are substantially equivalent to other attachments currently being marketed by Star, Midwest, KAVO, W&H, NSK and Champion Dental. Materials used to manufacture the components are similar. Means of operation are identical, compressed air powers a variable speed rotary vane motor to provide power to the attachments through a geared drive train for various dental procedures. The differentiation between the predicate devices and the submitted is the redesign of standard lubricated bearings to non-lubricated bearings and bushings.

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Image /page/1/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract image of an eagle or other bird-like figure. The image is black and white.

JAN 8 1999

Food and Druq Administration 9200 Corporate Boulevard Rockville MD 20850

Mr. William Guscott Product Development Engineer StarDental®, Division of DentalEZ® 1816 Colonial Village Lane Lancaster, Pennsylvania 17601

Re : K983574 StarDental® TITAN® 3 Lubefree Motor Trade Name: Attachments Regulatory Class: I Product Code: EGS Dated: September 29, 1998 Received: October 13, 1998

Dear Mr. Guscott:

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 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). 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 (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Requlations, Title 21, Parts 800 to 895. ਜੋ substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Requlation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP requlation may result in requlatory In addition, FDA may publish further announcements action. 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

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Page 2 - Mr. Guscott

through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

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 Also, please note the Office of Compliance at [phone]. the requlation entitled, "Misbranding by reference to premarket notification" (21CFR 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/dsma/dsmamafin.html" .

Sincerely yours,

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 Intended Use

Low speed dental attachments are used intraorally by trained dental professionals for drilling and preparation of dental cavities for restoration, such as fillings. Furthermore, the intended use extends to disking, cavity and crown preps, polishing, post and pin drilling and pin setting. The intended use is identical to that of the predicate low speed motor attachments.

Suan Reaser

(Division Sign-Off) Division of Dental, Infection Control, and General Hospital Devices 108 510(k) Number

Prescription Use
(Per 21 CFR 801.109)