DEXIS SENSOR

K090458 · Dexis, LLC · MUH · May 28, 2009 · Dental

Device Facts

• Record ID: K090458
• Device Name: DEXIS SENSOR
• Applicant: Dexis, LLC
• Product Code: MUH · Dental
• Decision Date: May 28, 2009
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.1800
• Device Class: Class 2

Intended Use

The DEXIS sensor is a USB-driven digital sensor which is intended to acquire dental intra-oral radiography images. The DEXIS sensor shall be operated by healthcare professionals, who are educated and competent to perform the acquisition of dental intraoral radiographs. The DEXIS sensor can be used either in combination with special positioning devices to facilitate positioning and alignment with the x-ray beam or it may also be positioned by hand with the assistance of the patient.

Device Story

DEXIS sensor is an indirect-converting digital X-ray detector; utilizes scintillating material to convert incident X-rays into visible light; light coupled to CMOS-based light detection imager. Device captures dental intra-oral images; connects to personal computers via USB 2.0/1.1 interface using dedicated electronic assembly and software driver. Operated by trained healthcare professionals in dental clinical settings; used with positioning devices or manual placement. Output consists of digital radiographic images displayed on PC for diagnostic use by dentists. Enables rapid acquisition and viewing of dental X-rays; facilitates clinical decision-making through digital image manipulation.

Clinical Evidence

Bench testing only. No clinical data provided.

Technological Characteristics

Indirect-converting X-ray detector; scintillating material coupled to CMOS light detection imager. USB 2.0/1.1 connectivity. Sensor dimensions: 30 x 39 mm. Dynamic range: 16,384:1. Cable length: 2.8 m. Operates via dedicated sensor software driver on PC.

Indications for Use

Indicated for dental patients requiring intra-oral radiographic imaging. Operated by trained healthcare professionals.

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.

Predicate Devices

• Schick Technologies, CDR (K072134)
• Suni Medical Imaging, Inc., SuniRay II Digital Radiographic System (K070219)

Submission Summary (Full Text)

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

Image /page/0/Picture/1 description: The image shows the logo for "sybron dental specialties". The text is in a bold, sans-serif font. A curved line is above the text, creating a visual element that frames the brand name.

K090458

## Section III - 510(k) Summary of Safety and Effectiveness

MAY 2.8 2009

Submitter:

Sybron Dental Specialties, Inc. 1717 West Collins Drive Orange, CA 92656 Claudia Ortiz - Contact Person

Date Summary Prepared: February 2009

Device Name:

- Trade Name DEXIS Sensor .
- Common Name Digital X-ray ●
- Classification Name Extraoral source x-ray system, per 21 CFR § 872.1800 .

### Devices for Which Substantial Equivalence is Claimed:

- Schick Technologies, CDR (K072134) ●
- Suni Medical Imaging, Inc., SuniRay II Digital Radiographic System (K070219) .

### Device Description:

The DEXIS sensor is an indirect converting x-ray detector, e.g. incident x-rays are converted by a scintillating material into (visible) light, this light is coupled optically to a light detection imager based on CMOS technology.

The design of the sensor assembly supports the automatic detection of the incident x-rays to generate digital images for dental intra-oral applications.

The DEXIS sensor supports USB 2.0 and USB 1.1 connectivity to personal computers using a dedicated electronic assembly and a sensor software driver.

## Intended Use of the Device:

The DEXIS sensor is a USB-driven digital sensor which is intended to acquire dental intra-oral radiography images. The DEXIS sensor shall be operated by healthcare professionals, who are educated and competent to perform the acquisition of dental intraoral radiographs. The DEXIS sensor can be used either in combination with special positioning devices to facilitate positioning and alignment with the x-ray beam or it may also be positioned by hand with the assistance of the patient.

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

Image /page/1/Picture/0 description: The image shows the logo for "sybron dental specialties". The text is in a bold, sans-serif font and is black. A curved line is above the text, starting from the left and ending above the "s" in "specialties".

## Substantial Equivalence:

| Descriptive<br>Information | DEXIS Sensor | CDR (K072134) | SuniRay II Digital<br>Radiographic System<br>(K070219) |
|----------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Indications<br>for Use | The DEXIS sensor is a<br>USB-driven digital sensor<br>which is intended to<br>acquire dental intra-oral<br>radiography images. The<br>DEXIS sensor shall be<br>operated by healthcare<br>professionals, who are<br>educated and competent to<br>perform the acquisition of<br>dental intra-oral<br>radiographs. The DEXIS<br>sensor can be used either in<br>combination with special<br>positioning devices to<br>facilitate positioning and<br>alignment with the x-ray<br>beam or it may also be<br>positioned by hand with the<br>assistance of the patient. | The computed oral radiology<br>system is intended for intra-<br>oral x-ray examinations and<br>indicated for dental patients. It<br>produces instant, digital, intra-<br>oral x-ray images of a<br>patient's mouth while<br>reducing the necessary x-ray<br>dosage. | The SuniRay II Digital<br>Radiography System is used<br>to collect dental x-ray<br>photons and convert them<br>into electronic impulses that<br>may be stored, viewed, and<br>manipulated for diagnostic<br>use by dentists. |
| Number of<br>Sensors | 1 | 3 | 2 |
| Sensor Size<br>(mm) | 30 x 39 | 31 x 22<br>37 x 24<br>43 x 30 | 39.5 x 26<br>43.5 x 31.5 |
| Technology | CMOS | Same | Same |
| Interface to<br>PC | USB | Same | Same |
| Dynamic<br>Range | 16,384:1 | 4096:1 | 4096:1 |
| Sensor Cable<br>Length (m) | 2.8 | 2 | 1 |

Conclusion: The DEXIS Sensor is substantially equivalent to other legally marketed devices in the The DEXIS Sensor is substantially equivalent in intended use and technical United States. characteristics to the CDR marketed by Schick Technologies, Inc. and SuniRay II Digital Radiographic System marketed by Suni Medical Imaging, Inc.

. ***

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

Image /page/2/Picture/0 description: The image is a circular seal or logo. The seal contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the top half of the circle. In the center of the seal is a stylized image of an eagle or bird with its wings spread, facing to the right. The bird's body is represented by three curved lines.

#### DEPARTMENT OF HEALTH & HUMAN SERVICES

## MAY 28 2009

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

DEXIS, LLC

% Ms. Claudia Ortiz

Compliance Director, Regulatory Affairs & Quality Assurance Sybron Dental Specialties, Inc. 1717 West Collins Drive

ORANGE CA 92656

Re: K090458

Trade/Device Name: DEXIS Sensor Regulation Number: 21 CFR 872.1800 Regulation Name: Extraoral source x-ray system Regulatory Class: II Product Code: MUH Dated: May 8, 2009 Received: May 11, 2009

#### Dear Ms. Ortiz:

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 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.

{3}------------------------------------------------

Page 2

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Center for Devices and Radiological Health's (CDRH's) Office of Compliance at one of the following numbers, based on the regulation number at the top of this letter.

21 CFR 876.xxx 21 CFR 884.xxx 21 CFR 892.xxx Other

(Gastroenterology/Renal/Urology) (Obstetrics/Gynecology) (Radiology)

[phone] [phone] [phone] [phone]

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 contact the CDRH/Office of Surveillance and Biometrics/Division of Postmarket Surveillance at 240-276-3464. For more information regarding the reporting of adverse events, please go to http://www.fda.gov/cdrh/mdr/.

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/cdrh/industry/support/index.html.

Sincerely yours,

Janine M. Morris Acting Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

{4}------------------------------------------------

# Indications for Use

510(k) Number (if known): K090458

Device Name: DEXIS Sensor

#### Indications for Use:

The DEXIS sensor is a USB-driven digital sensor which is intended to acquire dental intra-oral radiography images. The DEXIS sensor shall be operated by healthcare professionals, who are educated and competent to perform the acquisition of dental intraoral radiographs. The DEXIS sensor can be used either in combination with special positioning devices to facilitate positioning and alignment with the x-ray beam or it may also be positioned by hand with the assistance of the patient.

Prescription Use X (Part 21 CFR 801 Subpart D) AND/OR

Over-The-Counter Use (21 CFR 807 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

(Division Sign-Off)
Division of Reproductive, Abdominal and
Radiological Devices
510(k) Number K090454

Page 1 of 1

1