AMC-20 PORTABLE DENTAL CART MODEL AMC-20

K101332 · Aseptico, Inc. · EIA · Apr 11, 2011 · Dental

Device Facts

• Record ID: K101332
• Device Name: AMC-20 PORTABLE DENTAL CART MODEL AMC-20
• Applicant: Aseptico, Inc.
• Product Code: EIA · Dental
• Decision Date: Apr 11, 2011
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.6640
• Device Class: Class 1

Intended Use

The AMC-20 is a self-contained mobile dental cart that is used for general dentistry and endodontic applications.

Device Story

The AMC-20 is a self-contained mobile dental cart designed for use in clinical dental settings. It provides a portable platform for general dentistry and endodontic procedures. The device functions as a support unit for dental instruments and accessories, facilitating dental care delivery by clinicians. It does not involve complex data processing, software, or automated clinical decision-making.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Self-contained mobile dental cart. Operates as a mechanical support unit for dental instrumentation. No software, electronic sensing, or complex energy sources described.

Indications for Use

Indicated for use in general dentistry and endodontic applications by dental professionals.

Regulatory Classification

Identification

A dental operative unit and accessories is an AC-powered device that is intended to supply power to and serve as a base for other dental devices, such as a dental handpiece, a dental operating light, an air or water syringe unit, and oral cavity evacuator, a suction operative unit, and other dental devices and accessories. The device may be attached to a dental chair.

Submission Summary (Full Text)

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## DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/0/Picture/1 description: The image shows the logo for the Department of Health & Human Services USA. The logo features a stylized eagle with three lines representing its wings, body, and tail. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged in a circular pattern around the eagle.

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

Ms. Cherie A. Tregoning Regulatory Affairs Associate Aseptico, Incorporated 8333 216th Street, SE Woodinville, Washington 98072

APR 1 1 201

Re: K101332

Trade/Device Name: AMC-20 Mobile Dental Cart Regulation Number: 21 CFR 872.6640 Regulation Name: Dental Operative Unit and Accessories Regulatory Class: I Product Code: EIA Dated: March 22, 2011 Received: March 24, 2011

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 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/Safetv/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,

Wh for

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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Image /page/2/Picture/0 description: The image shows the word "ASEPTICO" in a stylized font. The first letter "A" is connected to a spiral-shaped design on the left side. A line extends from the right side of the word, adding a decorative element to the overall design.

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

## Indications for Use

510(k) Number (if known): K101332

Device Name: AMC-20 Mobile Dental Cart

Indications for Use:

The AMC-20 is a self-contained mobile dental cart that is used for general dentistry and endodontic applications.

Prescription Use X (Part 21 CFR 801 Subpart D)

AND/OR

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

Susan Renne

(Division Sign-Off)
Division of Anesthesiology, General Hospital
Infection Control and Dental Devices
510(k) Number 1873327