PRODRIVE LINE OF DENTAL HANDPIECES

K090369 · Prodrive Systems, Inc. · EFB · Feb 27, 2009 · Dental

Device Facts

• Record ID: K090369
• Device Name: PRODRIVE LINE OF DENTAL HANDPIECES
• Applicant: Prodrive Systems, Inc.
• Product Code: EFB · Dental
• Decision Date: Feb 27, 2009
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.4200
• Device Class: Class 1
• Attributes: Therapeutic, 3rd-Party Reviewed

Intended Use

The ProDrive Line of Dental Handpieces is intended for use by authorized persons in the practice of dentistry. The intended use of the ProDrive Line of Dental Handpieces is identical to that of the Predicate Device.

Device Story

High-speed air-driven dental handpieces (Mini and Standard models) used in dental operatory by authorized dental professionals. Inputs: air power for turbine rotation; carbide or diamond cutting instruments. Operation: push-button spindle mechanism grips bur shanks; unique geometry locks bur to turbine to prevent slippage/disengagement. Features: halogen light source (~25,000 lux); 3-jet water spray; bur indexing to extended position for improved visibility. Output: mechanical rotation of cutting instrument for cavity preparation and tooth cleaning. Benefits: improved performance, durability, and safety via secure locking mechanism; enhanced visibility.

Clinical Evidence

Bench testing only. Device conforms to ISO 7785-1:1997(E) performance standards. Testing confirmed the handpiece meets all performance requirements after 250 sterilization/use cycles.

Technological Characteristics

High-speed air-driven dental handpiece; push-button spindle mechanism; halogen light source (25,000 lux); 3-jet water spray; compatible with various quick couplings (Sirona, KaVo, W&H, Bien-Air, NSK). Conforms to ISO 7785-1:1997(E).

Indications for Use

Indicated for use in the dental operatory to prepare dental cavities for restorations such as fillings, and for cleaning teeth.

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

• T1 LINE Dental Handpieces (K972436)

Submission Summary (Full Text)

{0}------------------------------------------------

Image /page/0/Picture/0 description: The image shows the logo for Prodrive Systems. The logo features the word "PRODRIVE" in bold, sans-serif font, with a circle containing a dot in place of the letter "O". Below the word "PRODRIVE" is the word "SYSTEMS" in a smaller, sans-serif font.

一: -

KD90369

# 510(k) SUMMARY

# ProDrive Line of Dental Handpieces ProDrive Systems Inc.

FEB 2 7 2009

#### Owned by:

ProDrive Systems Inc. 812 Commerce Drive Ogdensburg, NY 13669 USA

#### Contact Person:

Timothy F. Nason, PhD Director of Regulatory Affairs ProDrive Systems Inc. 812 Commerce Drive Ogdensburg, NY 13669 USA

### Date of Summary:

January 9, 2009

#### Device Name:

Proprietary Name: Common Name: Classification Name: Product Code:

ProDrive Line of Dental Handpieces dental handpiece Handpiece, Air-powered, Dental EFB ("Dental handpiece and accessories", 21CFR 872.4200)

#### Predicate Device:

Proprietary Name: 510(k) Number: Product Code:

T1 LINE Dental Handpieces K972436 EFB

5

{1}------------------------------------------------

#### Description of Device:

The ProDrive line of high-speed air-driven dental handpieces includes two models - the ProDrive Mini and ProDrive Standard. These models are each available with one of a variety of quick couplings for use with: Sirona, KaVo, W&H, Bien-Air, NSK Mach and NSK QD-J connections. In addition, the PD Standard model comes in a fixed coupling format for MidWest handpiece users.

The handpieces come supplied with a halogen light source of approximately 25,000 lux and a 3 jet spray for water. Every ProDrive handpiece is equipped with the previously-cleared ProDrive turbine as the standard drive mechanism.

The ProDrive turbine is appropriate for use with ProDrive carbide and diamond cutting instruments. A push-button spindle mechanism is used to grip the shanks of the cutting instruments. The unique geometry of the bur shank and turbine spindle securely locks the bur in the turbine eliminating the slipping that can occur over time with traditional burs and turbines. In addition to improved performance and durability, the secure locking mechanism enhances the safety of the ProDrive Replacement Turbine by reducing the risk of accidental disengagement of burs from the handpiece during operation.

In addition, the ProDrive system incorporates the ability to index the bur to a second, extended, position effectively improving on the visibility angle and the utility of the handpiece without adversely affecting its performance.

The ProDrive line of dental handpieces meets or exceeds all of the applicable performances standards outlined in ISO 7785-1:1997(E). Extensive testing indicates that after 250 sterilization/use cycles the ProDrive handpiece continues to meet all performance requirements.

#### Intended Use of Device:

The ProDrive Line of Dental Handpieces is intended for use by authorized persons in the practice of dentistry. The intended use of the ProDrive Line of Dental Handpieces is identical to that of the Predicate Device.

{2}------------------------------------------------

Image /page/2/Picture/0 description: The image shows the logo for Prodrive Systems. The logo consists of the word "PRODRIVE" in bold, block letters, with a circle containing a stylized design in place of the "O". Below the word "PRODRIVE" is the word "SYSTEMS" in smaller, sans-serif letters. The text "Harness Performance through Innovation" is below the logo in a smaller font.

### Comparison of Technological Characteristics to Predicate Device:

The following table compares the features of the ProDrive Line of Dental Handpieces to the Predicate Device:

| TECHNOLOGICAL CHARACTERISTIC | COMPARISON TO PREDICATE |
|--------------------------------------------------|-------------------------|
| Intended use | Identical |
| Indications for use | Identical |
| Target population | Identical |
| Anatomical sites | Identical |
| Where used | Identical |
| Energy used and/or delivered | Similar |
| Human factors | Similar |
| Design | Similar |
| Performance | Similar |
| Standards met | Identical |
| Materials | Similar |
| Biocompatibility | Identical |
| Compatibility with environment and other devices | Identical |
| Sterility | Identical |
| Electrical safety | Identical |
| Mechanical safety | Identical |
| Chemical Safety | Identical |
| Thermal safety | Identical |
| Radiation safety | Identical |

# Table 1: Substantial Equivalence Table

# Conclusions Drawn from Technical Comparison:

The ProDrive Line of Dental handpieces is essentially the same as the predicate device in terms of its intended use, operating principles and materials.

The ProDrive Line of Dental handpieces conforms to the ISO 7785-1:1997(E) standard and the FDA Guidance Document on Dental Handpieces.

Therefore, we conclude that the ProDrive Line of Dental handpieces is both safe and effective for its intended use.

{3}------------------------------------------------

Public Health Service

Image /page/3/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" arranged around the perimeter. Inside the circle is a stylized image of an eagle with its wings outstretched.

APR 23 2009

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

ProDrive Systems, Incorporated C/0 Mr. Mark Job Responsible Third Party Official Regulatory Technology Services, LLC 1394 25th Street NW Buffalo, Minnesota 55313

Re: K090369

> Trade/Device Name: The ProDrive Line of Dental Handpieces Regulation Number: 21 CFR 872.4200 Regulation Name: Dental Handpiece and Accessories Regulatory Class: I Product Code: EFB Dated: February 12, 2009 Received: February 13, 2009

Dear Mr. Job:

This letter corrects our substantially equivalent letter of February 27, 2009.

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 (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 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.

{4}------------------------------------------------

## Page 2-Mr. Job

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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820): and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Center for Devices and Radiological Health's (CDRH's) Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please contact the CDRH/Office of Surveillance and Biometrics/Division of Postmarket Surveillance at 240-276-3464. For more information regarding the reporting of adverse events, please go to http://www.fda.gov/cdrh/mdr/.

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 [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours.

Susan Suara

Susan Runner, D.D.S., MA Acting Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

{5}------------------------------------------------

# Indications for Use

510(k) Number (if known): Not yet assigned

Device Name:

The ProDrive Line of Dental Handpieces

Indications For Use:

To be used in the dental operatory to prepare dental cavities for restorations such as fillings, and for cleaning teeth.

Prescription Use x (Part 21 CFR 801 Subpart D) AND/OR

Over-The-Counter Use (21 CFR 801 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Supa Russer

(Division Sign-Off) Division of Anesthesiology, General Hospital Infection Control, Dental Devices

Page 1 of 1

19026 510(k) Number: