TRUE VISION, TRUE VISION II

K974542 · Medical Dynamics, Inc. · EIA · Feb 17, 1998 · Dental

Device Facts

• Record ID: K974542
• Device Name: TRUE VISION, TRUE VISION II
• Applicant: Medical Dynamics, Inc.
• Product Code: EIA · Dental
• Decision Date: Feb 17, 1998
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.6640
• Device Class: Class 1

Intended Use

These intra-oral Dental Cameras are for use in dentistry to be able to show the patient abnormalities and pathology within the mouth. The cameras are utilized exclusively to inform the patient of conditions in the mouth which require treatment. It is not intended that the dental intra-oral camera be utilized in any dental operative procedure.

Device Story

Intra-oral dental camera system; captures visual images of oral cavity; displays images to patient for educational purposes regarding pathology and treatment needs. Operated by dental professionals in clinical setting. System includes handpiece with disposable, single-use, optically clear distal covering. Device is non-sterile; not compatible with sterilization processes. Output used solely for patient communication; does not guide or perform operative procedures.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Intra-oral camera system; non-sterile; non-sterilizable; includes single-use disposable distal handpiece covers. No electronic or software-based processing described.

Indications for Use

Indicated for use in dentistry to visualize oral abnormalities and pathology for patient education regarding required treatment. Not for use in dental operative 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.

Submission Summary (Full Text)

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DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration
9200 Corporate Boulevard
Rockville MD 20850

FEB 17 1998

Edwin L. Adair, M.D.
Director
Medical Dynamics, Incorporated
99 Inverness Drive, East
Englewood, Colorado 80112

Re: K974542
Trade Name: True Vision, True Vision II
Regulatory Class: I
Product Code: EIA
Dated: November 28, 1997
Received: December 3, 1997

Dear Dr. Adair:

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 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 II (Special Controls) or 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 Regulations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirement, 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

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Page 2 - Dr. Adair

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/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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13037991378 MEDICAL DYNAMICS T-092 P-006 DEC 11 '97 14:39
12/10/97 WED 12:17 FAX [phone] FDA/ODE/DDIGD 002
Page ____ of ____

510(k) Number (if known): (Not known at this time)

Device Name: Intra-Oral Dental Camera

Indications For Use: These intra-oral Dental Cameras are for use in dentistry to be able to show the patient abnormalities and pathology within the mouth. The cameras are utilized exclusively to inform the patient of conditions in the mouth which require treatment. It is not intended that the dental intra-oral camera be utilized in any dental operative procedure.

The camera is provided NON-STERILE and the camera is not built so that it can tolerate any sterilization process.

The camera system does provide a "clean", optically clear covering for the distal end of the handpiece. This provides a "clean" covering for the distal handpiece, and is intended for one time use only.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

(Division Sign-Off)
Division of Dental, Infection Control,
and General Hospital Devices
510(k) Number 8474542

Prescription Use ☑ (Per 21 CFR 801.109) OR Over-The-Counter Use ☐ (Optional Format 1-2-96)