(34 days)
Gendex GX-DC, Gendex GX-770
No
The document describes a standard dental X-ray system with fixed parameters and predefined exposure times, with no mention of AI or ML capabilities in the device description, intended use, or performance studies.
No.
The device is an x-ray system used for dental imaging, which is a diagnostic tool, not a therapeutic one. It does not treat or cure any condition.
No
This device is an X-ray system used to generate images, which are then used by a clinician for diagnosis. The device itself does not perform the diagnosis.
No
The device description explicitly lists multiple hardware components (X-ray tubehead, Yoke, Articulation arm, etc.) and describes a physical system for generating X-rays. It is not solely software.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body (like blood, urine, tissue) to detect diseases, conditions, or infections. These tests are performed outside the body (in vitro).
- Device Function: The Gendex 765DC Intraoral Dental X-Ray System is an extraoral source of x-rays used to create images of the teeth and surrounding structures within the body (in vivo). It does not analyze samples taken from the body.
- Intended Use: The intended use clearly states it's for "Dental Radiography," which is an imaging technique, not an in vitro diagnostic test.
The device is an imaging device used for diagnostic purposes, but it falls under the category of radiological medical devices, not in vitro diagnostics.
N/A
Intended Use / Indications for Use
The 765DC Intraoral Dental X-Ray System is to be used and an extraoral source of x-rays in Dental Radiography.
Product codes
90 EHD
Device Description
The Dentsply/Gendex 765DC Intraoral Dental X-Ray System is an extraoral source of x-rays for intraoral images in dental radiography.
The Dentsply/Gendex 765DC Intraoral Dental X-Ray System is comprised of the following main components:
- X-ray tubehead .
- . Yoke with user interface capabilities
- Articulation arm .
- Horizontal arm .
- Electronic control unit (which my be mounted remotely) .
- . Wall mount
- . 8" or 20cm cone
Optional components:
- 8 ft. coil cord with exposure switch .
- 55" and 65" reach option .
- · Optional cone lengths and shapes
The power supply is regulated to provide a fixed 65kVp, and the x-ray target current is fixed at 7ma. Predefined exposure times may be selected directly through the control or yoke switchpads. The range of exposure time is 0.02 through 2.00 seconds.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
x-rays
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
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)
Safety and Effectiveness is demonstrated by:
- Performance testing to meet product specifications
- Software testing to validate software design / performance ﺍ
- Effective clinical image exposures ו
- Hazard analysis including risk level and solution ।
- Same indications for use as predicate devices. ।
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Sirona Heliodent DS ., Planmeca Prostyle Intra ., Gendex GX-DC, Gendex GX-770
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
SEP 7 1999
Image /page/0/Picture/2 description: The image shows the logos for Dentsply and Gendex. The Dentsply logo is in all caps and bolded. The Gendex logo is in a smaller font and is located below the Dentsply logo.
)
GENDEX Dental X-Ray Division Dentsply International Inc. 901 West Oakton Street Des Plaines, IL 60018-1884 Phone (847) 640-4800 (847) 640-4970 FAX
510(k) Summary Statement for the Gendex 765DC Intraoral Dental X-Ray System
I General Information
| Submitter: | Gendex Dental X-Ray Division of Dentsply International, Inc.
901 West Oakton St.
Des Plaines, IL 60018 |
| ------------ | -------------------------------------------------------------------------------------------------------------- |
|---|
(847) 640-4800 – Company Number Telephone: (847) 640-4908 - Contact Person
Fax: (847) 640-4970
Daniel P. Murphy Contact Person: Director of Operations
Summary Preparation Date: August 4, 1999
II Names
Gendex 765DC Device Name: Intraoral Dental X-Ray System
Primary Classification Name: 76EHD - Unit, X-Ray, Extraoral with Timer
III Predicate Devices
- Sirona Heliodent DS .
- Planmeca Prostyle Intra .
- . Gendex GX-DC
- . Gendex GX-770
00196 00197
1
IV Product Description
The Dentsply/Gendex 765DC Intraoral Dental X-Ray System is an extraoral source of x-rays for intraoral images in dental radiography.
The Dentsply/Gendex 765DC Intraoral Dental X-Ray System is comprised of the following main components:
- X-ray tubehead .
- . Yoke with user interface capabilities
- Articulation arm .
- Horizontal arm .
- Electronic control unit (which my be mounted remotely) .
- . Wall mount
- . 8" or 20cm cone
Optional components:
- 8 ft. coil cord with exposure switch .
- 55" and 65" reach option .
- · Optional cone lengths and shapes
The power supply is regulated to provide a fixed 65kVp, and the x-ray target current is fixed at 7ma. Predefined exposure times may be selected directly through the control or yoke switchpads. The range of exposure time is 0.02 through 2.00 seconds.
V Indications for Use / Rationale for Substantial Equivalence
The 765DC Intraoral Dental X-Ray System is to be used and an extraoral source of x-rays in Dental Radiography.
It shares the same indications for use, similar materials, design, operational, and functional features and therefore is substantially equivalent to the predicate devices listed in section III of this summary.
00197 00198
2
VI Safety and Effectiveness Information
Safety and Effectiveness is demonstrated by:
- Performance testing to meet product specifications
- Software testing to validate software design / performance ﺍ
- Effective clinical image exposures ו
- Hazard analysis including risk level and solution ।
- Same indications for use as predicate devices. ।
All the above steps and evaluations combine to demonstrate that the 765CD Intraoral Dental X-Ray System is safe and effective when the device is used as labeled.
VII Conclusion
The Gendex 765DC Intraoral Dental X-Ray System was found to be is Substantially Equivalent to the predicate devices; the Sirona Heliodent DS, the Planmeca Prostyle Intra, the Gendex OX-770, and the Gendex GX-DC. The Gendex 765DC Intraoral Dental X-Ray System shares the same indications for use, similar materials, design, operational, and functional features as the current marketed predicate devices. It has been shown to be safe and effective when used as labeled.
3
DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Image /page/3/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of an eagle with three lines extending from its head, representing the department's mission to protect the health of all Americans and provide essential human services.
7 1999 SEP
Mr. Daniel P. Murphy Director of Operations GENDEX Dental X-Ray Division Dentsply International Inc. 901 West Oakton Street Des Plaines, IL 60018-1884
Dear Mr. Murphy:
Re:
K992610 Gendex 765DC ™ Intraoral Dental X-Rav System Dated: August 4, 1999 Received: August 4, 1999 Requiatory Class: II (two) Product Code: 90 EHD 21 CFR 872.1800
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 (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 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 Requlations, 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 regulation may result in regulatory 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.qov/cdrh/dsma/dsmamain.html".
Sincerely yours,
OART Daniel O. Schultz, M.D.
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
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
4
510(k) Number (if known): Not Assigned
Device Name:
Gendex 765DC Intraoral Dental X-Ray System
Indications for Use:
The Gendex 765DC Intraoral Dental X-Ray System is to be used as an extraoral source of x-rays in Dental Radiography.
(PLEASE DO NOT WRITE BELOW THIS LINE -- CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use
(Per 21 CFR 801.109)
Daniel A. Synn
(Division Sign-Off)
Division of Reproductive, Abdominal, ENT, and Radiological Devices
and Radiological Devic 510(k) Number
Prescription Use (Per 21CFR 801.109) OR
Over-The-Counter Use _
(Optional Format 1-2-96)