PREVA, 76IN ARM, 66IN ARM, 56IN ARM, MODELS P7017, P7016, P7015

K043092 · Progeny, Inc. · EHD · Dec 13, 2004 · Dental

Device Facts

• Record ID: K043092
• Device Name: PREVA, 76IN ARM, 66IN ARM, 56IN ARM, MODELS P7017, P7016, P7015
• Applicant: Progeny, Inc.
• Product Code: EHD · Dental
• Decision Date: Dec 13, 2004
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.1800
• Device Class: Class 2

Intended Use

The intended use of the Progeny PREVA Extra-Oral X-Ray system is to act as a diagnostic source for radiographic dental imaging.

Device Story

The PREVA Intraoral Dental X-Ray System is an extraoral x-ray source used in dental clinics to produce intraoral radiographs. The system comprises a tubehead, rotating yoke, articulation arm, horizontal extension arm, electronic control unit, and wall mount. It utilizes an 8-inch or 12-inch cone for beam collimation. The operator selects kVp (60, 65, or 70), tube current (4, 6, or 8 mA), and exposure time (0.01 to 2.00 seconds) via a control panel. Exposure is initiated by the operator using a deadman switch. The device provides the x-ray beam necessary for capturing dental images, which the clinician then uses for diagnostic assessment of dental structures. The system benefits patients by enabling high-quality diagnostic imaging for dental treatment planning.

Clinical Evidence

No clinical data. Safety and effectiveness were demonstrated through bench testing, performance verification against product specifications, software validation, and hazard/risk analysis.

Technological Characteristics

Extraoral x-ray source; selectable kVp (60, 65, 70) and mA (4, 6, 8); articulated arm suspension; deadman switch exposure control; 8-inch or 12-inch cone; electronic control unit. Software is used for system control and exposure timing.

Indications for Use

Indicated for use as an extraoral source of x-rays for diagnostic dental radiography in patients requiring intraoral radiographs.

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

• Gendex Gx-770 (K935046)
• Gendex 765DC (K992610)

Submission Summary (Full Text)

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## 510(k) Summary

# DEC 1 3 2004

as required by CFR section 807.92(c)

Koy 3092

### I. General Information

- November 6, 2004 Date:
- Progeny, Inc. Applicant: 1807 Barclay Blvd. Buffalo Grove, Ill. 60089
- Alan Krema Contact Person:
- 847-850-3800 x785 Telephone:
- 847-850-3800 Fax:

#### II. Names

Device Name:

| Trade Name: | PREVA |
|----------------------|---------------------------------------------|
| Common Name: | Intra Oral X-Ray System |
| Classification Name: | 76 EHD – Unit, X-Ray, Extra oral with Timer |

#### III. Predicate Devices

Gendex Gx-770 Gendex 765DC

#### IV. Product Description

The Progeny, Inc. PREVA Intraoral Dental X-Ray System is an extraoral source of x-rays for intraoral radiographs in dental diagnostic radiography.

The Progeny, Inc. PREVA Intraoral Dental X-Ray System consists of the following main components:

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K04301Z

X-ray tubehead Rotating yoke for tubehead mounting Articulation arm Horizontal extension arm Electronic control unit Wall mount 8 inch cone

Optional Components:

12 inch cone 8 ft. coil cord with exposure switch

The Power supply is regulated to provide a selectable 60, 65, or 70 kVp at a selectable tube current of 4, 6,0r 8 mA. Predefined exposure times may be selected via the operator control panel. The range of exposure times is 0.01 to 2.00 seconds.

#### V. Indications for Use / Rationale for Substantial Equivalence

The PREVA Intraoral Dental X-Ray System is to be used as an extraoral source of xrays in Dental radiography.

The PREVA shares the same indications for use, materials, design, operational and functional features and is therefore substantially equivalent to the predicate devices listed in section III of this summary.

There are several major independent manufacturers of Intra Oral diagnostic Radiographic Systems on the U.S. market. One is the Dentsply Gx770. The 510(k) number is K935046 . The classification of the Dentsply device is listed as product code 76EHD.

The other currently marketed device is the Gendex 765, manufactured by Dentsply, Inc. the 510(k) number is K992610. The classification of the Gendex 765 is listed as product code 76EHD .

Labeling for the currently marketed devices is included as Appendix B.

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Progeny Inc.

| Characteristic | Gx 770 | Gendex 765 | Progeny PREVA |
|---------------------------------|---------------------------|---------------------------|------------------------------|
| Kv | 70 kVp fixed | 65 kVp fixed | 60, 65, 70 kVp, selected |
| mA | 7.0 mA | 7.5 mA | 4, 6, 8mA, selected |
| Operator Technique<br>Selection | Exposure<br>Duration Only | Exposure<br>Duration Only | kV, mA, Exposure<br>Duration |
| Suspension | Articulated Arm | Articulated Arm | Articulated Arm |
| X-Ray Field Size | 6.5 cm diameter | 6.0 cm diameter | 6.5 cm diameter |
| Focal Distance | 8 in. cone<br>12 in. cone | 8 in. cone | 8 in. cone<br>12 in. cone |
| Operator Exposure<br>Control | Deadman<br>Switch | Deadman<br>Switch | Deadman<br>Switch |

#### VI. Safety and Effectiveness Information

Safety and effectiveness is demonstrated by:

Performance testing and verification to meet product specifications. Software testing to validate software design and performance. Hazard analysis and risk level assessment. Same indications for use as predicate devices.

All of the above steps and evaluations combine to demonstrate that the PREVA Intraoral Dental X-Ray System is safe and effective when the device is used as labelled.

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Ku43092

### VII. Conclusion

The Progeny, Inc. PREVA Intraoral Dental X-Ray System is determined to be substantially equivalent to the predicate devices, the Gendex Gx-770, and the Gendex 765DC. The PREVA shares the same indications for use, materials, design, operational and functional features to the currently marketed predicate devices listed in section III of this summary. The PREVA Intraoral Dental X-Ray System is safe and effective when the device is used as labelled.

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Image /page/4/Picture/1 description: The image shows a circular logo for the Department of Health & Human Services - USA. The logo features a stylized eagle with three curved lines representing its wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged around the top half of the circle.

#### Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850'

# DEC 1 3 2004

Mr. Alan Krema Director of Product Development Progeny, Inc. 1407 Barclay Blvd. BUFFALO GROVE IL 60089

Re: K043092

Trade/Device Name: PREVA Extraoral X-Ray System Regulation Number: 21 CFR 872.1800 Regulation Name: Extraoral source x-ray system Regulatory Class: II

Product Code: 90 EHD Dated: November 3, 2004 Received: November 15, 2004

Dear Mr. Krema:

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 (Premarket Approval), it may be subject to such 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 Section 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:

| 21 CFR 876.xxxx | (Gastroenterology/Renal/Urology) | 240-276-0115 |
|-----------------|----------------------------------|--------------|
| 21 CFR 884.xxxx | (Obstetrics/Gynecology) | 240-276-0115 |
| 21 CFR 892.xxxx | (Radiology) | 240-276-0120 |
| Other | | 240-276-0100 |

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). 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/dsmadsmam.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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# Indications for Use

510(k) Number (if known):_____K043092

PREVA Device Name: _________________________________________________________________________________________________________________________________________________________________

Indications For Use:

The intended use of the Progeny PREVA Extra-Oral X-Ray system is to act as a diagnostic source for radiographic dental imaging.:

Prescription Use
(Part 21 CFR 801 Subpart D)

AND/OR

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

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Nancy C. Broadon

(Division Sign-Off) Division of Reproductive Abdomina and Radiological Devices 510(k) Number _

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