(84 days)
Not Found
No
The description focuses on basic image capture, storage, and display functionalities typical of a standard intraoral camera, with no mention of AI/ML terms or capabilities like automated analysis, diagnosis, or feature detection.
No
The device is used to provide a view of the mouth to assist the dentist in describing dental procedures and to show a patient before and after views of his/her mouth. It is explicitly stated that these devices are "not intended to aid in dental surgical procedures." This indicates that the device is for visual communication and documentation rather than direct treatment or therapy.
No
Explanation: The device is described as an intraoral video camera used to visualize the mouth, assist in describing dental procedures, and show before and after views to patients. It is explicitly stated that these are "not intended to aid in dental surgical procedures" and the primary use is for "visual communication directly to the patient" and educational purposes, not for diagnosing conditions.
No
The device description explicitly details hardware components such as a video camera, digital memory, foot switch, push button, rod lens scope, and a unit that can be detached for autoclaving. This indicates it is a hardware device with integrated software, not a software-only medical device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the device is used to "provide a view of the mouth in order to assist the dentist in describing dental procedures and to show a patient before and after views of his/her mouth showing the patient results of the dental procedures." It explicitly states, "These are not intended to aid in dental surgical procedures." This purpose is for visual communication and patient education, not for diagnosing a disease or condition based on in vitro examination of specimens.
- Device Description: The description focuses on capturing and displaying images of the oral cavity for visual communication. It doesn't mention any analysis of biological samples or substances.
- Lack of IVD Characteristics: An IVD device typically involves the examination of specimens derived from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening. This device does not perform such functions.
The device is an intraoral video camera used for visualization and communication within the oral cavity, which falls under the category of medical devices, but not specifically In Vitro Diagnostic devices.
N/A
Intended Use / Indications for Use
The iDENT-A100 Intraoral Video Camera of the Confident Technology Inc. is used to provide a view of the mouth in order to assist the dentist in describing dental procedures and to show a patient before and after views of his/her mouth showing the patient results of the dental procedures which the dentist has performed on him/her. These are not intended to aid in dental surgical procedures.
Product codes
EIA
Device Description
The iDENT-A100 Intraoral Video Camera provides clear, high resolution images of the oral cavity, which can be stored and manipulated in the new built digital memory and used for visual communication directly to the patient. The System can capture one full image or can capture four images into one frame and the captured images can be display on a video monitor. The operation of the capturing image can be done by a foot switch or a push button and is very user-friendly. The typical dentist and assistant can use the system with a few minutes training.
A high resolution, true color image is produced on the screen by a rod lens scope design which is the standard in the industry for endoscopic procedures. There is no peripheral distortion of the image. Manual focusing is not required and a single tooth or full arch view can be captured without changing the scope. The unit is easily detached for autoclaving cleaning.
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Video
Anatomical Site
mouth / oral cavity
Indicated Patient Age Range
Not Found
Intended User / Care Setting
dentist and assistant
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)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc)
Not Found
§ 872.6640 Dental operative unit and accessories.
(a)
Identification. A dental operative unit and accessories is an AC-powered device that is intended to supply power to and serve as a base for other dental devices, such as a dental handpiece, a dental operating light, an air or water syringe unit, and oral cavity evacuator, a suction operative unit, and other dental devices and accessories. The device may be attached to a dental chair.(b)
Classification. Class I (general controls). Except for dental operative unit, accessories are exempt from premarket notification procedures in subpart E of part 807 of this chapter subject to § 872.9.
0
SECTION 9 510(k) SUMMARY OF SAFETY AND EFFECTIVENESS
JAN 3 0 2002
This 510(k) summary of safetly and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and CFR 807.92(c).
| Submitter: | Confident Technology Inc.
13841 Roswell Ave. # K
Chino, CA 91710
Tel: 909-590 8665 Fax: 909-5909664 |
|---------------------------|--------------------------------------------------------------------------------------------------------------|
| Contact Person: | Lewis Lin
Tel: 909-590 8665 Fax: 909-5909664 |
| Date Prepared: | 10/30/2001 |
| Trade / Proprietary Name: | iDENT-A100 Intraoral Video Camera |
| Common/Usual Names: | Intraoral video camera |
| Classification Names: | Dental Operative Unit and Accessories (76 EIA)
Class I |
Description of the Device:
The iDENT-A100 Intraoral Video Camera provides clear, high resolution images of the oral cavity, which can be stored and manipulated in the built digital memory and used for visual communication directly to the patient. The System can capture one full image or can capture four images into one frame and the captured images can be display on a video monitor. The operation of the capturing image can be done by a foot switch or a push button and is very user-friendly. The typical dentist and assistant can use the system with a few minutes training.
A high resolution, true color image is produced on the screen by a rod lens scope design which is the standard in the industry for endoscopic procedures. There is no peripheral distortion of the image. Manual focusing is not required and a single tooth or full arch view can be captured without changing the scope. The unit is easily detached for autoclaving cleaning.
Indications for use:
The iDENT-A100 Intraoral Video Camera of the Confident Technology Inc. is used to provide a view of the mouth in order to assist the dentist in describing dental
1
procedures and to show a patient before and after views of his/her mouth showing the patient results of the dental procedures which the dentist has performed on him/her. These are not intended to aid in dental surgical procedures.
Predicate Device:
W. EDWARD JOHANSEN's ULTRACAM cleared under 510(k) K973410 on 10/08/1998 and AIR TECHNIQUES, INC.'s VISTACAM OMNI AND VIASTCAM OMNI (IC) cleared under 510(k) K974204 on 01/08/1998.
Rationale for Substantial Equivalence:
The iDENT-A100 Intraoral Video Camera shares the same indications for use as the predicate devices. Since the design is comparable, technology virtually identical, the specifications very similar.
Conclusion:
Based on the supportive documentation and descriptions outlined in this premarket notifications-510 (k), we believe that the iDENT-A100 Intraoral video camera is substantially equivalent to those of similar types of products, used for parallel purposes, currently on the market. The iDENT-A100 Intraoral Video Camera was found to be substantially equivalent to the predicate devices.
End of Summary
2
Image /page/2/Picture/1 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" arranged around the perimeter. Inside the circle is a stylized image of an eagle with three wing-like shapes, representing the department's mission to protect the health of all Americans and provide essential human services.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JAN 3 0 2002
Mr. Lewis Lin President Confident Technology, Incorporated 13841 Roswell Avenue #K Chino, California 91710
Re: K013690
Trade/Device Name: iDENT-A100 Intraoral Video Camera Regulation Number: 872.6640 Regulation Name: Intraoral Video Camera Regulatory Class: I Product Code: EIA Dated: October 31, 2001 Received: November 7, 2001
Dear Mr. Lin:
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 mendments, 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 approvisions 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 such additional controls. Existing major regulations affecting (111) 10 mm) of the Code of Federal Regulations, Title 21, Parts 800 to 898. In your device ear or roundsh 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.
3
Page 2 - Mr. Lin
You must comply with all the Act's requirements, including, but not limited to: registration Tourinust comply with an the Pro e reg (21 CFR Part 801); good manufacturing practice in allu listing (21 OF Part 807), and its systems (QS) regulation (21 CFR Part 820); and if requirements us set form in are quadiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
This letter will allow you to begin marketing your device as described in your Section This letter will and w you to began internet mages.
510(k) premarket notification. The FDA finding of substantial equivalence of your device to 310(K) premained nounceared wice 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 If you desire up of CFR Part 809.10 for in vitro diagnostic devices), please contact the and additionally 21 OF 1 (301) 594-4613. Additionally, for questions on the promotion and Office of Comphance at e, please contact the Office of Compliance at (301) 594-4639. also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers, International and the Act may of counter 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,
Timothy A. Ulatowski Director Division of Dental, Infection Control and General Hospital Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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iDENT-A100 Intraoral Video Camera Original Premarket 510(k) Notification
INDICATION FOR USE
K013690
510(k) Number :
To Be Assigned By FDA
Device Name:
iDENT-A100 Intraoral video camera
Indication for Use:
The iDENT-A100 Intraoral video camera of the Confident Technology Inc. is used to provide a view of the mouth in order to assist the dentist in describing dental procedures and to show a patient before and after views of his/her mouth showing the patient results of the dental procedures which the dentist has performed on him/her.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Susan Munro
Division Sign-Off) Division of Dental, Infection Control, a General Hospital Devices F : (i(k) Number . K812190
| Prescription Use | ✓ |
|---|---|
| or Over-The-Counter Use |
(Per 21 CFR 801.109)
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