K Number
K990049
Device Name
CD-DENT DIGITAL IMAGING DEVICES FOR DENTAL X-RAY SYSTEMS, MODELS 600, 1000 AND 2000
Manufacturer
Date Cleared
1999-03-12

(64 days)

Product Code
Regulation Number
872.1800
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
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 diagnostic intraoral and extraoral images.
Device Description
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.
More Information

No
The summary describes a digital imaging system for dental X-rays that uses phosphor storage screens and software for display, enhancement, and storage. There is no mention of AI or ML in the intended use, device description, or specific sections for AI/ML information. The focus is on digitizing and managing images, not on automated analysis or interpretation using AI/ML.

No.
The device is intended for digital dental radiography for diagnostic imaging purposes, not for treating any condition.

Yes

The 'Intended Use / Indications for Use' section explicitly states that the device is "intended for radiographic diagnostic intraoral and extraoral images," directly indicating its diagnostic purpose. It is a tool for acquiring images that will be used for diagnosis, not for treating or preventing disease.

No

The device description explicitly states it consists of reusable phosphor storage screens and an image reader/digitizer, which are hardware components.

Based on the provided information, this device is not an IVD (In Vitro Diagnostic).

Here's why:

  • Intended Use: The intended use clearly states "digital dental radiography using a phosphor storage screen for radiographic diagnostic intraoral and extraoral images." This describes a system for capturing and displaying medical images, not for performing tests on biological samples (like blood, urine, or tissue) to diagnose a condition.
  • Device Description: The description details components like phosphor storage screens, an image reader/digitizer, and software for displaying and storing images. These are all related to medical imaging, not in vitro testing.
  • Lack of IVD Characteristics: There is no mention of analyzing biological samples, reagents, or any process that would involve testing something in vitro (outside of the body).

IVD devices are specifically designed to perform tests on samples taken from the human body to provide information for diagnosis, monitoring, or screening. This device is for capturing and processing images of the body itself.

N/A

Intended Use / 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 diagnostic intraoral and extraoral images.

Product codes

90 MUH

Device Description

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.

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Dental X-Ray Systems

Anatomical Site

Dental intraoral, extraoral, and cephalometric

Indicated Patient Age Range

Not Found

Intended User / Care Setting

Dentist

Description of the training set, sample size, data source, and annotation protocol

Not Found

Description of the test set, sample size, data source, and annotation protocol

Not Found

Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)

Not Found

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

Not Found

Predicate Device(s)

K974619, K934949, K955643

Reference Device(s)

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information

Not Found

§ 872.1800 Extraoral source x-ray system.

(a)
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.(b)
Classification. Class II.

0

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: 011 972 4 959 1262 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)

1

  • 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.

2

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.

.

:

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 (301) 594-4613. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. 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 (800) 638-2041 or (301) 443-6597, 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

3

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)

CONFIDENTIAL Page v