AXENIC DHP DISPOSABLE HIGH-PERFORMANCE HANDPIECE

K072754 · Axenic Dental, Inc. · EFB · Jan 25, 2008 · Dental

Device Facts

• Record ID: K072754
• Device Name: AXENIC DHP DISPOSABLE HIGH-PERFORMANCE HANDPIECE
• Applicant: Axenic Dental, Inc.
• Product Code: EFB · Dental
• Decision Date: Jan 25, 2008
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.4200
• Device Class: Class 1
• Attributes: Therapeutic

Intended Use

The Axenic Dental, Inc. DHP™ "Disposable High-Performance" sterile, pyrogen free, maintenance free handpiece, with appropriate burs, is indicated for all dental practice procedures for which metal handpieces are used, including cutting, shaping and preparing teeth for cavity repair, crowns and bridges. The device is suitable for use in circumstances where infectious, inter-patient contamination is a concern. The device can be used for duration of 12 to 14 minutes cutting time during single patient use.

Device Story

The Axenic DHP™ is a sterile, single-patient-use, disposable dental handpiece. It functions as a high-speed instrument for cutting, shaping, and preparing teeth. Operated by dental professionals in clinical settings, it replaces traditional reusable metal or plastic handpieces. The device is designed for a maximum of 12 to 14 minutes of continuous cutting time. Because it is disposable, it eliminates the need for cleaning, maintenance, or sterilization between patients, thereby reducing the risk of infectious inter-patient contamination. The clinician attaches appropriate burs to the handpiece to perform standard dental procedures.

Clinical Evidence

Bench testing only. No clinical data provided.

Technological Characteristics

Disposable, single-patient-use dental handpiece. Materials of construction are similar to standard reusable metal or plastic handpieces. Designed for high-speed operation with a 12-14 minute functional limit. Sterile and pyrogen-free. No software or electronic components.

Indications for Use

Indicated for dental patients requiring tooth cutting, shaping, or preparation for cavity repair, crowns, and bridges. For professional use by dental health providers. Suitable for scenarios where inter-patient contamination is a concern.

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

• OralSafe™ Disposable Handpieces (K923469)

Submission Summary (Full Text)

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## Axenic Dental, Inc., Premarket Notification - 510(k), DHP™ "Disposable High-Ferformance" Handpiece, Model DHP™

## SECTION 5: 510(k) Summary

| Submitter: | Axenic Dental, Inc. |
|------------|------------------------|
| | 259 East Michigan |
| | Suite 409, 4th Floor |
| | Kalamazoo, MI 49007 |
| Contact: | Joseph T. Sobota, M.D. |
| | 269-349-8870 |

K072754

JAN 25 25.0

Axenic Dental DHPTM, Disposable High-Performance Handpiece Name of Device:

Predicate Device: OralSafe™ Disposable Handpieces, K923469

Description of the New Device: The Axenic Dental, Inc. DHP™ "Disposable High-Performance Handpiece" is a sterile, single patient use, disposable instrument that is substantially equivalent to standard, re-usable, metal or plastic handpieces. All Axenic DHP™, high-speed, dental hand pieces are designed to operate at maximum specification outputs for 12 to 14 minutes of use. The single patient use nature of the instrument precludes any necessity for maintenance, cleaning, or sterilization.

INTENDED USE OF THE NEW DEVICE: The Axenic Dental, Inc. DHP™ "Disposable High-Performance" handpiece, with appropriate burs, is indicated for all dental practice procedures for which metal handpieces are used, including cutting, shaping and preparing teeth for cavity repair, crowns and bridges. The device is suitable for use in circumstances where infectious inter-patient contamination is a concern. The device can be used for duration of 12 to 14 minutes cutting time during single patient use.

Comparison of the Technological Features of the New [Modified] Device and Predicate Devices: The modified device and the lawfully marketed predicate device contain similar materials of construction. Features of the modified device are comparable to those of the predicate device with the exception that the modified device includes sterility and pyrogen free indications and is maintenance free. These enhancements will not negatively affect the safety or effectiveness of the device.

Signed,

Joseph T. Sobota, M.D. Chief Regulatory Executive Axenic Dental, Inc.

DHP™ is a Registered Trademark of Axenic Dental, Inc.

CONFIDENTIAL

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Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle or bird-like symbol on the right side. To the left of the symbol, the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the symbol. The text is in all caps.

Public Health Service

JAN 25 2008

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Mr. Joseph Sobota Chief Regulatory Executive Axenic Dental, Incorporated 295 East Michigan Suite 409, 4th Floor Kalamazoo, Michigan 49007

Re: K072754

Trade/Device Name: Axenic DHP™ "Disposable High-Performance" Handpiece, Model DHPTM Regulation Number: 21 CFR 872.4200 Regulation Name: Dental Handpiece and Accessories Regulatory Class: I Product Code: EFB Dated: January 18, 2008 Received: January 22, 2008

Dear Mr. Sobota:

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 application (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 such 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.

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Page 2 - Mr. Sobota

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); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if 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) 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 regulation (21 CFR Part 801), please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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,

Suritz y. Michie. ms.

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

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Axenic Dental, Inc., Premarket Notification - 510(k), DHP™ "Disposable High-Performance" Handpiece, Model DHP™

SECTION 4: INSTRUCTIONS FOR USE

510(k) Number:

CTIONS FOR USE

K072754

Device Name:

Axenic DHP™ "Disposable High-Performance" Handpiece, Model DHP™

The Axenic Dental, Inc. DHP™ "Disposable High-Performance" sterile, pyrogen free, maintenance free handpiece, with appropriate burs, is indicated for all dental practice procedures for which metal handpieces are used, including cutting, shaping and preparing teeth for cavity repair, crowns and bridges. The device is suitable for use in circumstances where infectious, inter-patient contamination is a concern. The device can be used for duration of 12 to 14 minutes cutting time during single patient use.

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use or Over-the-Counter Use

For Professional Use Only (Dental Health Provider) X

Susan Runny

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

510(k) Number: K072754

CONFIDENTIAL

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