AEU-6000 IMPLANT / ENDODONTIC DENTAL SYSTEM

K142124 · Aseptico, Inc. · EKX · Dec 31, 2014 · Dental

Device Facts

• Record ID: K142124
• Device Name: AEU-6000 IMPLANT / ENDODONTIC DENTAL SYSTEM
• Applicant: Aseptico, Inc.
• Product Code: EKX · Dental
• Decision Date: Dec 31, 2014
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.4200
• Device Class: Class 1
• Attributes: Therapeutic

Intended Use

The AEU-6000-70V and AEU-6000 are drive systems for instruments and tools used in dentistry for implants/surgical procedures and endodontic procedures. The systems include an irrigation supply and a wide range of user controls designed to provide drilling during osteotomy preparation and implant placement or endodontic therapy.

Device Story

AEU-6000-70V and AEU-6000 are dental drive systems providing power and irrigation for surgical and endodontic handpieces. Used by dentists in clinical settings for osteotomy preparation, implant placement, and endodontic therapy. Systems feature user-controlled motor speed, torque, and irrigation flow. Device provides mechanical energy to dental tools; enables precise drilling and instrumentation during procedures. Benefits include controlled, efficient surgical and endodontic access and preparation.

Clinical Evidence

Bench testing only.

Technological Characteristics

Dental drive system for surgical/endodontic handpieces; includes motor control unit and irrigation pump. Operates via electrical power. Provides variable speed, torque, and irrigation control for dental instrumentation.

Indications for Use

Indicated for dental professionals performing implant, surgical, and endodontic procedures, including osteotomy preparation and implant placement.

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 Center - WO66-G609 Silver Spring, MD 20993-0002

December 31, 2014

Aseptico, Incorporated Ms. Cherie Tregoning Regulatory Affairs Specialist 8333 216th Street Southeast Woodinville, Washington 98072

Re: K142124

Trade/Device Name: AEU-6000-70V & AEU-6000 Implant/Surgical & Endodontic Dental Systems Regulation Number: 21 CFR 872.4200 Regulation Name: Dental Handpiece and Accessories Regulatory Class: I Product Code: EKX Dated: December 1, 2014 Received: December 1, 2014

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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Page 2 - Ms. Tregoning

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 contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree number [phone] or [phone] or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. 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/ResourcesforYou/Industry/default.htm.

Sincerely yours,

Susan Runno DDS, MA

Erin I. Keith, M.S. Director Division of Anesthesiology, General Hospital, Respiratory, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Image /page/2/Picture/1 description: The image shows the logo for Aseptico, a company that specializes in advancing dental technology. The logo features a blue swirl design next to the company name in bold, black letters. Contact information is listed to the right of the logo, including the phone number 800.426.5913, fax number 360.668.8722, and website www.aseptico.com.

## Indications for Use

Device Name: AEU-6000-70V & AEU-6000 Implant/Surgical & Endodontic Dental Systems

Indications for Use:

The AEU-6000-70V and AEU-6000 are drive systems for instruments and tools used in dentistry for implants/surgical procedures and endodontic procedures. The systems include an irrigation supply and a wide range of user controls designed to provide drilling during osteotomy preparation and implant placement or endodontic therapy.

Prescription Use X (Part 21 CFR 801 Subpart D)

AND/OR

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