AEU-7000L-70V IMPLANT/ENDODONTIC DENTAL SYSTEM (LIGHTED VERSION)

K150129 · Aseptico, Inc. · EKX · May 28, 2015 · Dental

Device Facts

• Record ID: K150129
• Device Name: AEU-7000L-70V IMPLANT/ENDODONTIC DENTAL SYSTEM (LIGHTED VERSION)
• Applicant: Aseptico, Inc.
• Product Code: EKX · Dental
• Decision Date: May 28, 2015
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.4200
• Device Class: Class 1
• Attributes: Therapeutic

Intended Use

The AEU-700L-70V is a drive system for instruments and tools used in dentistry for implants / surgical and endodontic procedures. The system includes 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-7000L-70V is a dental drive system for surgical and endodontic procedures. Device provides power and irrigation to handpieces used for osteotomy preparation, implant placement, and endodontic therapy. Operated by dental professionals in clinical settings. System includes user controls for adjusting speed, torque, and irrigation flow. Output is mechanical rotation and fluid delivery to the surgical site, facilitating precise drilling and instrumentation. Benefits include controlled, efficient preparation of bone and root canal systems during dental surgery.

Clinical Evidence

Bench testing only.

Technological Characteristics

Electrically powered dental drive system. Includes irrigation pump, motor control unit, and user interface for speed/torque/flow regulation. Designed for use with dental handpieces. Sterilization of accessories per standard dental practice. No software-based automated analysis or AI/ML components.

Indications for Use

Indicated for use as a drive system for dental instruments and tools during implant/surgical procedures (osteotomy preparation, implant placement) and endodontic therapy.

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

May 28, 2015

Aseptico, Inc. Ms. Cherie Tregoning Regulatory Affairs Specialist 8333 216th Street South East Woodinville Washington, 98072

Re: K150129

Trade/Device Name: AEU-7000L-70V Implant/Endodontic Dental System Regulation Number: 21 CFR 872.4200 Regulation Name: Dental Handpiece and Accessories Regulatory Class: I Product Code: EKX Dated: April 24, 2015 Received: April 29, 2015

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 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,

Tina
Kiang -S

for 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/0 description: The image shows the logo for Aseptico, a company that specializes in advancing dental technology. The logo features the company name in a stylized font, with a blue swirl design to the left. 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-7000L-70V Implant / Endodontic Dental System

Indications for Use:

The AEU-700L-70V is a drive system for instruments and tools used in dentistry for implants / surgical and endodontic procedures. The system includes 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

And/Or

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