TRITON SELF CONTAINED DENTAL SYSTEM, TRITON SELF CONTAINED DENTAL SYSTEM, WITH CASE

K110481 · Asi Medical, Inc. · EIA · Apr 5, 2012 · Dental

Device Facts

• Record ID: K110481
• Device Name: TRITON SELF CONTAINED DENTAL SYSTEM, TRITON SELF CONTAINED DENTAL SYSTEM, WITH CASE
• Applicant: Asi Medical, Inc.
• Product Code: EIA · Dental
• Decision Date: Apr 5, 2012
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.6640
• Device Class: Class 1
• Attributes: Therapeutic

Intended Use

The ASI Triton Mobile Dental System (Models 2025 and 2025M) is a self-contained dental treatment unit that contains a built in air compressor, vacuum system and water supply. It is designed to provide air, water, vacuum and electricity to operate various dental handpieces, accessories and attachments and to serve as a base for other dental devices and accessories. The device is intended for use to provide general dental restorative care and hygiene procedures in both traditional dental office settings and/or mobile applications by or under the supervision of a licensed dentist or a hygienist if permitted by applicable law.

Device Story

Triton Self Contained Dental System (Models 2025/2025M) functions as mobile dental treatment unit; integrates air compressor, vacuum system, and water supply. Provides air, water, vacuum, and electricity to power dental handpieces and accessories. Used in traditional dental offices or mobile clinical settings; operated by licensed dentists or hygienists. Serves as base for dental instrumentation; facilitates restorative care and hygiene procedures.

Clinical Evidence

No clinical data; bench testing only.

Technological Characteristics

Self-contained dental unit; includes integrated air compressor, vacuum system, and water supply. Provides electrical power for handpieces. Form factor: mobile cart/unit. No software or algorithmic components.

Indications for Use

Indicated for patients requiring general dental restorative care and hygiene procedures. Intended for use in traditional dental offices or mobile settings by licensed dentists or hygienists.

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)

{0}------------------------------------------------

## DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle or bird-like figure with three curved lines representing its body and wings. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the bird-like figure.

## Public Health Service

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

APR - 5 2012

Mr. John McPeek President ASI Medical, Incorporated 14550 East Easter Avenue, Suite 700 Centennial, Colorado 80112

Re: K110481

Trade/Device Name: Triton Self Contained Dental System Regulation Number: 21 CFR 872.6640 Regulation Name: Dental operative unit and accessories Regulatory Class: I Product Code: EIA Dated: March 20, 2012 Received: March 21, 2012

Dear Mr. McPeek:

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 Eederal Register.

{1}------------------------------------------------

## Page 2- Mr. McPeek

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/ucm 1 15809.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.

Nh for

Anthony D. 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

{2}------------------------------------------------

## Indications for Use Form

510(k) Number (if known): K110481

Device Name: Triton Self Contained

Indications for Use:

The ASI Triton Mobile Dental System (Models 2025 and 2025M) is a self-contained dental treatment unit that contains a built in air compressor, vacuum system and water supply. It is designed to provide air, water, vacuum and electricity to operate various dental handpieces, accessories and attachments and to serve as a base for other dental devices and accessories.

The device is intended for use to provide general dental restorative care and hygiene procedures in both traditional dental office settings and/or mobile applications by or under the supervision of a licensed dentist or a hygienist if permitted by applicable law.

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

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)

Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)

Sheehatnee for MSR

Division Sign-Off Office of In Vitro Diagnostic Device Evaluation and Safety

510(k) k110481

Page 1 of