IDENT-A100 INTRAORAL VIDEO CAMERA

K013690 · Confident Technology, Inc. · EIA · Jan 30, 2002 · Dental

Device Facts

• Record ID: K013690
• Device Name: IDENT-A100 INTRAORAL VIDEO CAMERA
• Applicant: Confident Technology, Inc.
• Product Code: EIA · Dental
• Decision Date: Jan 30, 2002
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.6640
• Device Class: Class 1

Intended 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.

Device Story

Intraoral video camera captures high-resolution, true-color images of oral cavity; utilizes rod lens scope design; no manual focusing required; captures single or quad-image frames. Operated by dentist or assistant via foot switch or push button. Images stored in digital memory; displayed on video monitor for patient communication and education. Device detachable for autoclaving. Benefits include improved patient understanding of dental procedures and outcomes through visual demonstration.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Rod lens scope design; high-resolution, true-color imaging; digital memory storage; foot switch or push-button operation; detachable for autoclaving.

Indications for Use

Indicated for use by dentists to provide intraoral visualization for patient education and communication regarding dental procedures and results. Not intended to aid in dental surgical procedures.

Regulatory Classification

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.

Predicate Devices

• W. EDWARD JOHANSEN's ULTRACAM (K973410)
• AIR TECHNIQUES, INC.'s VISTACAM OMNI AND VIASTCAM OMNI (IC) (K974204)

Submission Summary (Full Text)

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# 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.<br>13841 Roswell Ave. # K<br>Chino, CA 91710<br>Tel: [phone] Fax: [phone] |
|---------------------------|--------------------------------------------------------------------------------------------------------------|
| Contact Person: | Lewis Lin<br>Tel: [phone] Fax: [phone] |
| 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)<br>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

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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

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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.

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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 [phone]. Additionally, for questions on the promotion and Office of Comphance at e, please contact the Office of Compliance at [phone]. 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 [phone] or [phone] 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 | <span style="text-decoration: underline;">✓</span> |
|-------------------------|----------------------------------------------------|
| or Over-The-Counter Use | <span style="text-decoration: underline;"></span> |

(Per 21 CFR 801.109)

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