PORTABLE HDX INTRAORAL X-RAY

K021378 · Dentalez Group · EHD · Jun 7, 2002 · Dental

Device Facts

• Record ID: K021378
• Device Name: PORTABLE HDX INTRAORAL X-RAY
• Applicant: Dentalez Group
• Product Code: EHD · Dental
• Decision Date: Jun 7, 2002
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.1800
• Device Class: Class 2
• Attributes: Pediatric

Intended Use

Portable HDX Intraoral X-ray is to be used only by a qualified/trained dentist or dental technician on both adult and pediatric subjects for taking diagnostic extraoral dental x-rays using intraoral image receptors. The usual safety precautions regarding the use of x-rays must be observed by the operator.

Device Story

Portable dental x-ray system; operates on 120 VAC or 240 VAC power. Utilizes Constant Emission Power (CEP) to minimize exposure time. Device can be tripod-mounted or handheld. Operator selects exposure time via interface buttons; system emits x-rays for diagnostic imaging using intraoral receptors. Used in dental clinical settings by dentists or technicians. Output provides diagnostic images for clinical decision-making; benefits patient through portable, efficient radiographic assessment.

Clinical Evidence

Bench testing only. Performance evaluated against 21 CFR 1020.30 and United States Government Specifications SP0200-96-R-8076. No clinical data provided.

Technological Characteristics

Portable extraoral x-ray system; 120V/240V AC power. Constant Emission Power (CEP) technology. Dimensions: 5.5" H x 8.25" W x 8" D (body). Exposure time: 0.01-2.00 seconds. Output: 65 kVp, 7 mA. Electrical safety standards: UL 2601, CSA 601-M90, EN 6061-1.

Indications for Use

Indicated for adult and pediatric patients requiring diagnostic extraoral dental x-rays using intraoral image receptors. To be used by qualified/trained dentists or dental technicians.

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

• MinXray HF70D (K000061)

Submission Summary (Full Text)

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K021378

Image /page/0/Picture/1 description: The image shows the logo for DentalEZ Group. The logo consists of the word "DentalEZ" in a bold, sans-serif font. Below the "EZ" portion of the word, the word "GROUP" is written in a smaller font. A curved line extends from the bottom of the "G" in "GROUP" and wraps around the right side of the logo.

7 2002 JUN

Star Dental Products 1816 Colonial Village Lane Lancaster, PA 17601-5864 717/291-1161 Fax [phone] www.dentalez.com

### 510(k) SUMMARY

## Portable HDX Intraoral X-ray April 29, 2002

- 1. Company: StarDental®, Division of DentalEZ® Owner/operator number 2520265
Contact Person: Deon Beck Manufacturing Engineer StarDental®, Division of DentalEZ® 1816 Colonial Village Lane Lancaster, PA 17601 717-291-1161 Telephone: Facsimile: 717-391-2757

- 2. Proprietary-Trade Name: Portable HDX Intraoral X-ray Classification Name: Extraoral source x-ray system (per 21 CFR section 872.1800) Portable Dental X-ray Common/Usual Name:
- 3. Predicate Devices:

MinXray HF70D (K000061) Literature is included at Tab 4.

#### 4. Description:

Portable HDX Intraoral X-ray is a portable dental x-ray system that operates on 120 VAC (+/-10%), 60 Hz, and 240 VAC (+/-10%), 50 Hz line AC power. The system uses Constant Emission Power (CEP) which allows for minimum exposure time and can be either mounted to a tripod or can be hand held.

Image /page/0/Picture/13 description: The image shows the logo for StarDental. The text "StarDental" is written in a bold, sans-serif font. To the right of the text is a stylized star symbol. The star is black and has a sharp, geometric design.

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#### 5. Intended Use:

Portable HDX Intraoral X-ray is to be used only by a qualified/trained dentist or dental technician on both adult and pediatric subjects for taking diagnostic extraoral dental x-rays using intraoral image receptors. The usual safety precautions regarding the use of x-rays must be observed by the operator.

#### 6. Safety and Effectiveness, comparison to predicate device:

The result of bench and user testing per Performance Standards 21 CFR § 1020.30 and United States Government Specifications SP0200-96-R-8076 (NSN 6525-01-425-5216) indicates that the new system is as safe and effective as the predicate devices.

| Feature | Portable HDX Intraoral X-ray | MinXray HF70D |
|-----------------------|-------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------|
| Intended Use: | Extraoral dental x-ray w/intraoral<br>receptors | SAME |
| Energy Source: | 120V 50 Hz or 240V Hz AC | 120V 50-60 Hz AC |
| Size: | Body: 5.5" H x 8.25 W x 8" D<br>Cone: 2.75" Dia. x 5.75" L | Body: 5.8" H x 4.8" W x 7.9" D<br>Cone: 2" Dia. x 6" L |
| Weight: | 11.7 lbs. | 10.4 lbs. |
| User Interface: | Up-down buttons for exposure time<br>selections with display. | Up-Down pushbuttons for three<br>kVp selections and exposure time<br>selection with indicators. |
| Exposure Times: | 0.01 -- 2.00 seconds in 0.01 increments | 0.02 - 1.98 seconds in 99 steps |
| mA: | 7 mA | 10 mA |
| kVp: | 65 kVp | 60, 65, 70 kVp |
| Performance Standard: | 21 CFR 1020.30,<br>United States Government Specifications<br>SP0200-96-R-8076 (NSN 6525-01-425-5216) | 21 CFR 1020.30 |
| Electrical Safety: | UL 2601, CSA 601-M90,<br>EN 6061-1:1990+A1+A2 | UL 2601, IEC 6061-1 |

#### 7. Substantial Equivalence Chart:

Image /page/1/Picture/6 description: The image shows the logo for StarDental. The text "StarDental" is written in a bold, sans-serif font. To the right of the text is a stylized star symbol, which is partially filled in with black.

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#### 8. Conclusion:

After analyzing all testing data and meeting performance standards and specifications it is the conclusion of DentalEZ that the "Portable HDX Intraoral X-ray" is as safe and effective as the predicate device. The system has few technological differences, and has no new indications for use, thus rendering it substantially equivalent to the predicate device.

Image /page/2/Picture/2 description: The image contains the text "StarDental" in a bold, sans-serif font. To the right of the text is a stylized graphic that resembles a star or an abstract geometric shape. The overall impression is that of a logo for a dental company named StarDental.

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Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of three human figures in profile, with their heads overlapping to create a sense of unity and connection.

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Mr. Deon Beck Manufacturing Engineer Dental EZ Group Star Dental Products 1816 Colonial Village Lane LANCASTER PA 17601-5864 Re: K021378

7 2002

JUN

Trade/Device Name: Portable HDX Intraoral X-ray system Regulation Number: 21 CFR 872.1800 Regulation Name: Extraoral source x-ray system Regulatory Class: II Product Code: 76 EHD Dated: April 29, 2002 Received: May 1, 2002

Dear Mr. Beck:

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.

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); 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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This letter will allow you to begin marketing your device as described in your 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at one of the following numbers, based on the regulation number at the top of this letter:

| 8xx.1xxx | [phone] |
|----------------------------------|----------------|
| 876.2xxx, 3xxx, 4xxx, 5xxx | [phone] |
| 884.2xxx, 3xxx, 4xxx, 5xxx, 6xxx | [phone] |
| 892.2xxx, 3xxx, 4xxx, 5xxx | [phone] |
| Other | [phone] |

Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained 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/dsma/dsmamain.html.

Sincerely yours,

Nancy C Brogdon

Nancy C. Brogdon Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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# Statement of Intended Use:

The Portable HDX Intraoral X-ray unit is intended for use only by a qualified/trained Fire Formore HD7P maderal 12 cm) adult and pediatric subjects for taking diagnostic extraoral dental x-rays using intraoral image receptors.

*Prescription Use*

David A. Sygnyn

(Division Sign-Off) Division of Reproductive, Abdominal, and Radiological Devices K021378 510(k) Number .