TIO-H DIGITAL RADIOGRAPHY SENSOR

K153144 · Denttio, Inc. · MUH · Feb 10, 2016 · Dental

Device Facts

• Record ID: K153144
• Device Name: TIO-H DIGITAL RADIOGRAPHY SENSOR
• Applicant: Denttio, Inc.
• Product Code: MUH · Dental
• Decision Date: Feb 10, 2016
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.1800
• Device Class: Class 2

Intended Use

The Tio-h Digital Radiography Sensor is a digital radiography imaging system and intended to be used by a qualified dental and healthcare professionals in order to perform basic dental intra-oral x-ray imaging procedures. The digital radiography sensor captures the X-rays produced by an external X-ray generator. It transmits the image data to the computer and displays the x-ray image on the computer screen that ultimately diagnose general dental complications or abnormalities.

Device Story

Tio-h Digital Radiography Sensor; intra-oral dental imaging system. Captures X-rays from external generator; transmits image data to computer; displays images on screen for clinician review. Used in dental clinics by dentists/healthcare professionals. Facilitates diagnosis of dental complications/abnormalities via digital visualization.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Digital radiography sensor; intra-oral form factor; connects to computer for image display; utilizes external X-ray generator source.

Indications for Use

Indicated for use by qualified dental and healthcare professionals to perform basic dental intra-oral x-ray imaging procedures for the diagnosis of general dental complications or abnormalities.

Regulatory Classification

Identification

An extraoral source x-ray system is an AC-powered device that produces x-rays and is intended for dental radiographic examination and diagnosis of diseases of the teeth, jaw, and oral structures. The x-ray source (a tube) is located outside the mouth. This generic type of device may include patient and equipment supports and component parts.

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

February 10, 2016

Denttio, Inc. % Mr. Young Han President 3235 N. San Fernando Road, Bldg. 7B LOS ANGELES CA 90065

Re: K153144

Trade/Device Name: Tio-h Digital Radiography Sensor Regulation Number: 21 CFR 872.1800 Regulation Name: Extraoral source x-ray system Regulatory Class: II Product Code: MUH Dated: January 20, 2016 Received: January 22, 2016

Dear Mr. Han:

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.

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.

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If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free 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" (21 CFR 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 Industry and Consumer Education at its toll-free number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours.

Michael D. O'Hara
For

Robert Ochs, Ph.D. Director Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health

Enclosure

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## Indications for Use

510(k) Number (if known) K153144

Device Name Tio-h Digital Radiography Sensor

## Indications for Use (Describe)

The Tio-h Digital Radiography Sensor is a digital radiography imaging system and intended to be used by a qualified dental and healthcare professionals in order to perform basic dental intra-oral x-ray imaging procedures. The digital radiography sensor captures the X-rays produced by an external X-ray generator. It transmits the image data to the computer and displays the x-ray image on the computer screen that ultimately diagnose general dental complications or abnormalities.

| Type of Use (Select one or both, as applicable) | |
|------------------------------------------------------------|-----------------------------------------------------------|
| <span></span> Prescription Use (Part 21 CER 801 Subpart D) | <span></span> Over-The-Counter Use (21 CER 801 Subpart C) |

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