GENERAL DENISTRY MOTOR

K103399 · Aseptico, Inc. · EKX · Feb 28, 2011 · Dental

Device Facts

• Record ID: K103399
• Device Name: GENERAL DENISTRY MOTOR
• Applicant: Aseptico, Inc.
• Product Code: EKX · Dental
• Decision Date: Feb 28, 2011
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.4200
• Device Class: Class 1
• Attributes: Therapeutic

Intended Use

Can be used for a wide range of dental procedures including endodontic surgeries, such as drilling into the root canal, and general dentistry, such as removing carious material from the dentin.

Device Story

AEU-5000 is a dental handpiece system used by dental professionals in clinical settings. It functions as a motorized tool for drilling and removing carious material during endodontic and general dental procedures. The device operates via electrical power to drive dental burs or instruments. It serves as a standard surgical/restorative instrument for dentists to perform cavity preparation and root canal access. The device benefits patients by facilitating precise removal of diseased tooth structure and enabling endodontic access.

Clinical Evidence

Bench testing only.

Technological Characteristics

Dental handpiece system; electrical power source; intended for dental drilling and material removal; classified as Class I, 21 CFR 872.4200, Product Code EKX.

Indications for Use

Indicated for dental procedures including endodontic surgeries (e.g., root canal drilling) and general dentistry (e.g., carious material removal).

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.

Submission Summary (Full Text)

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Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002

Ms. Cherie Tregoning Aseptico, Incorporated 8333 216th Street, S.E. Woodinville, Washington 98072

FEB 2 8 2011

Re: K103399

Trade/Device Name: AEU-5000 Regulation Number: 21 CFR 872.4200 Regulation Name: Dental Handpiece and Accessories Regulatory Class: I Product Code: EKX Dated: November 12, 2010 Received: November 30, 2010

Dear Ms. Tregoning:

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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

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.

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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 (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.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to

http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. 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 go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

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/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely yours,
Susan Perry

Anthony Watson, B.S., M.S., M.B.A. 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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ASEPTICO

Aseptico Inc., 8333 216". Street SE, Woodinville, WA 98072 U.S.A. Phone: [phone] FAX [phone]

November 2010

## Indications for Use Statement

510(k) Number (if known): K103399

Device Name: AEU-5000

Indication for Use Statement

Can be used for a wide range of dental procedures including endodontic surgeries, such as drilling into the root canal, and general dentistry, such as removing carious material from the dentin.

Prescription Use X (Part 21 CFR 801 Subpart D)

AND/OR

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

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1/15/2029

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