CD-DENT DIGITAL IMAGING DEVICES FOR DENTAL X-RAY SYSTEMS, MODELS 600, 1000 AND 2000

K990049 · Digident , Ltd. · MUH · Mar 12, 1999 · Dental

Device Facts

• Record ID: K990049
• Device Name: CD-DENT DIGITAL IMAGING DEVICES FOR DENTAL X-RAY SYSTEMS, MODELS 600, 1000 AND 2000
• Applicant: Digident , Ltd.
• Product Code: MUH · Dental
• Decision Date: Mar 12, 1999
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.1800
• Device Class: Class 2

Intended Use

The CD-Dent Digital-Imaging Devices for Dental X-Ray Systems are intended for digital dental radiography using a phosphor storage screen for radiographic intraoral and extraoral images

Device Story

CD-Dent Digital Imaging Devices are filmless systems for dental radiography; utilize reusable phosphor storage screens to record radiographic images; include image reader/digitizer and software. System captures X-ray data via phosphor screens; reader digitizes latent image; software processes, displays, enhances, and stores images on user-provided PC. Used in dental clinics by dentists/staff. Output allows review and storage of dental radiographs; assists in diagnostic decision-making; provides digital workflow benefits over traditional film.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Filmless digital radiography system; utilizes reusable phosphor storage screens; includes image reader/digitizer and software for PC-based image processing/storage. Operates as an accessory to dental X-ray systems.

Indications for Use

Indicated for digital dental radiography in patients requiring intraoral and extraoral radiographic diagnostic imaging.

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

• ScanARay Computerized X-Ray System (K974619)
• Digora (K934949)
• DenOptix System (K955643)

Submission Summary (Full Text)

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K990049

.

# 510(k) Summary

for

CD-Dent Digital-Imaging Device for Dental X-Ray Systems

#### DATE SUMMARY PREPARED 1.

January 4, 1999

## SUBMITTER'S NAME AND ADDRESS 2.

Digident Ltd. Yoqneam Star Bldg. Yoqneam P.O. Box 465 Nesher 36603 Israel

#### CONTACT PERSON 3.

Mr. Betzalel Halevi 011 972 4 959 1331 Telephone: [phone] Facsimile:

## DEVICE NAME 4.

| Trade/Proprietary Name: | CD-Dent Digital Imaging Devices for Dental X-Ray Systems, Models 600, 1000, and 2000 |
|-------------------------|--------------------------------------------------------------------------------------|
| Common Name: | Accessory to Electrostatic X-Ray imaging system (Dental) |
| Classification Name: | Accessory to Electrostatic X-Ray imaging system |

#### ડ. PREDICATE DEVICES

The legally marketed devices to which equivalence is being claimed are:

- ScanARay Computerized X-Ray System marketed by AFP Imaging . (K974619)

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- Digora marketed by Sorodex-finndent (K934949) .
- DenOptix System marketed by Gendex (K955643) .

# DEVICE DESCRIPTION 6.

The CD-Dent Digital Imaging Devices for Dental X-Ray Systems are filmless systems intended for digital intraoral, extraoral and cephalometric radiography using a phosphor storage screen. They enable the dentist to scan or import images for display, review or storage in a database. They consist of reusable phosphor storage screens for recording radiographic images, an image reader/digitizer, and software for displaying, enhancing, and storing dental radiographs using a userprovided personal computer.

# INTENDED USE 7.

The CD-Dent Digital Imaging Devices for Dental X-Ray Systems are intended for digital dental radiography using a phosphor storage screen for radiographic diagnostic intraoral and extraoral images.

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Image /page/2/Picture/0 description: The image shows the text "DEPARTMENT OF HEALTH & HUMAN SERVICES" in a bold, sans-serif font. The text is arranged on a single line and appears to be part of a document or header. The words are capitalized and evenly spaced.

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:

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Digident, LTD c/o Mary M. McNamara-Cullinane, RAC Staff Consultant Medical Device Consultants. Inc. 49 Plain Street North Attleboro. MA 02760

.. Re: K990049 CD-Dent Digital-Imaging Devices for : ・ ・ ・ ・ ・ ・ ・ ・ ・ ・ ・ ・ ・ ・ ・ ・ ・ ・ ・ ・ ・ ・ ・ ・ ・ ・ ・ ・ ・ ・ ・ ・ ・ ・ ・ ・ ・ ・ ・ ・ ・ ・ ・ ・ ・ ・ ・ ・ ・ ・ ・ ・ ・ ・ ・ ・ ・ ・ ・ ・ ・ ・ ・ ・ ・ ・ ・ ・ ・ ・ ・ ・ ・ ・ ・ ・ ・ ・ ・ ・ ・ ・ ・ ・ ・ ・ Dental X-Ray Systems Dated: January 6, 1999 Received: January 7, 1999 : 21 CFR 872.1800/Procode: 90 MUH

Dear Ms. McNamara-Cullinane:

MAR 1 2 1999

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we 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, 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 dass 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 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP requiration may result in requlatory action. In addition. FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

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 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at [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 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number [phone] or [phone], or at its internet address "http://www.fda.gov/cdrh/dsma/dsmamain.html".

Sincerely yours,

CAPT Daniel G. Schultz, M.D. Acting Director, Division of Reproductive, Abdominal, Ear, Nose and Throat, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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510(k) Number (if known): _

Device Name: _________________________________________________________________________________________________________________________________________________________________

Indications For Use:

The CD-Dent Digital-Imaging Devices for Dental X-Ray Systems are intended for digital dental radiography using a phosphor storage screen for radiographic intraoral and extraoral images

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

David A. Legum

(Division Sign-Off) Division of Reproductive, Abdominal, ENT, and Radiological Devic 510(k) Number

Prescription Use _ (Per 21 CFR 801.109)

OR

Over-The-Counter Use _________________________________________________________________________________________________________________________________________________________

(Optional Format 1-2-96)

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