AEU-14CF EXPENDITION

{0}------------------------------------------------ KOSOAOI Image /page/0/Picture/1 description: The image shows a logo for "ASEPCO International" along with the date "MAR 18 2005" above the logo. The logo is stylized with a decorative font and a horizontal line extending from the left side. The word "International" is written in a smaller, italicized font below the main logo. The image appears to be a scan or photocopy, as the text and logo are in black and white. Aseptico Inc. · 8333 216" St SE · Woodinville, WA 98072 Telephone: (425) 487-3157 Fax: (360) 668-8722 Web: www.aseptico.com E-mail: grant@aseptico.com # 510(k) Summary Contact: Grant Ramaley Date Prepared: December 7, 2004 Trade or Proprietary Name: AEU-14CF Expedition Field Dental System Classification Name: 872.6640 Unit, Operative Dental 510(k) Number: #### Device Description: The AEU-14CF Expedition is a portable electric dental system intended to provide basic dentistry capabilities in emergency and field situations. The Expedition features an "E" type autoclavable 30,000 RPM brushless micro motor with interchangeable headpieces, a 3-way air/water syringe, a self-contained water system, and an oil-less air compressor. The Expedition is powered by internal 27.6V battery packs, and may be connected to a 120V/230V AC power source or to a 12/24V vehicle battery for extended operation or recharging. A detachable solar panel is also provided for recharging the internal batteries when other sources are not available. ### Features of Substantial Equivalence to Aseptico Model AEU-425 [510(k) K022217] - 1) Autoclavable low-voltage electric micro motor - 2) Forward, reverse, and speed control for handpiece motor - 3) Accepts standard "E" Type handpieces - 4) Adjustable coolant flow to handpiece for high-speed applications. - 5) Operates on either 120/230VAC mains power - 6) The 3-way air/water syringe for irrigation, misting, and drying - 7) Footswitch for On/Off control of handpiece motor and coolant - 8) Self-contained water system and air reserve tank #### Other Features: - 1) Can operate on internal, rechargeable NiHM batteries. This battery technology is used in the Medtronic Lifepak 20 Defibrillator/Monitor [510(k) K012274] {1}------------------------------------------------ ## PREMARKET NOTIFICATION ## truthful and accurate statement I certify that, in my capacity as Director of Quality and Regulatory Affairs of r centiry that, in my oupdoxy as a the best of my knowledge, that all data and Aseptico, incorporated, I bonove to the boot of the best of the program and that no material fact has been omitted. | | <div> <img alt="Signature" src="signature.png" width="200"/> </div> | |---------------|---------------------------------------------------------------------| | (Signature) | | | Grant Ramaley | | | (Typed Name) | | | 12-28-2004 | | | (Dated) | | (Premarket Notification [510(k)] Number) {2}------------------------------------------------ Image /page/2/Picture/1 description: The image shows the seal of the Department of Health and Human Services (HHS). The seal features a stylized eagle with three lines forming its body and head. The words "DEPARTMENT OF HEALTH AND HUMAN SERVICES. USA" are arranged in a circular pattern around the eagle. Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850 MAR 1 8 2005 Aseptico, Incorporated C/O Ms. Melissa J. DeGuia Associate Project Engineer/Reviewer Underwriters Laboratories, Incorporated 2600 N.W. Lake Road Camas, Washington 98607-8542 Re: K050201 Trade/Device Name: EXPEDITION Field Dental System, Model Number AEU-14CF Regulation Number: 872.6640 Regulation Name: Dental Operative Unit and Accessories Regulatory Class: I Product Code: EIA Dated: March 11, 2005 Reccived: March 14, 2005 Dear Ms. DeGuia: We have reviewed your Section 510(k) premarket notification of intent to market the device we nave revealed 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 microate oomineres prives that have been reclassified in accordance with the provisions of Amendinens, or to are , 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 approvial applisions of the Act. The general controls provisions of the Act include controls provisions of a 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 (1 Mr.), I may of bagger of Federal Regulations, Title 21, Parts 800 to 898. In your device tax may publish further announcements concerning your device in the Federal Register. {3}------------------------------------------------ ### Page 2 - Ms. DeGuia Please be advised that FDA's issuance of a substantial equivalence determination does not Please be advised that FDA 3 issualled on that your device complies with other requirements mean that IDA has made a deceminations administered by other Federal agencies. of the Act of ally rederal surates and registments, including, but not limited to: registration You must comply with an the Fee Isquing (21 CFR Part 801); good manufacturing practice and ifsiing (21 CFR Part 607), laoeling (21 CFR Pat 820), and if requirements as set forth in the quality brovisions (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) This letter will anow you to ough mading of substantial equivalence of your device to a premarket nothleation. The PDF milling or woussification 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), If you desire specific ad ree for Joinese at (240) 276-0115. Also, please note the regulation prease contact the Office or Other in premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Ifray other general mironmanenes, International and Consumer Assistance at its toll-free Division of Billian of Since (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html. Sincerely yours, Sinar Gunno 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 {4}------------------------------------------------ # Indications for Use 510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________ Device Name: _EXPEDITION Field Dental System, Model Number AEU-14CF _ Indications for Use: The EXPEDITION offers the dental professional the capability of carrying a The EXFLEDTHON one transportable case. The system is complete dental operative oyetemental procedures anywhere there is a suitable surable for performing gollord. Contain and be operated on internal power source. Tidationally, and a recharged using a detachable solar panel. Prescription Use _____________________________________________________________________________________________________________________________________________________________ (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE) Susan Russo logy, General Hospital Control, Dental Devices (OTC) sa20 Page 6