(91 days)
The intraoral camera system, Digital Doc, of Digital Doc, 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 mouth showing the patient results of the dental procedures which the dentist has performed on him.
Not Found
The provided document is a 510(k) premarket notification letter from the FDA for a device called "Digital Doc." It confirms that the device is substantially equivalent to legally marketed predicate devices. However, this document does not contain any information about acceptance criteria or a study proving the device meets acceptance criteria.
The letter primarily focuses on:
- The FDA's review of the 510(k) submission.
- The determination of substantial equivalence.
- Regulatory classifications and requirements.
- Instructions for marketing the device.
- Contact information for further inquiries.
The "Indications for Use" section (page 2 of the uploaded document) describes the purpose of the device (to provide a view of the mouth for dentists to describe procedures and show before/after views to patients), but it does not specify performance metrics or studies.
Therefore, I cannot provide the requested information, as none of it is present in the provided text.
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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized depiction of a human figure with three overlapping profiles, suggesting a sense of community and interconnectedness. The profiles are rendered in black and are arranged in a way that creates a sense of depth and movement. Encircling the figure is the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" in a circular arrangement.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
AUG 1 0 1998
Mr. W. Edward Johansen Digital Doc, Incorporated 11661 San Vicente Boulevard Los Angeles, California 90049
Re : K981663 Diqital Doc Trade Name: Requlatory Class: I Product Code: EIA July 22, 1998 Dated: Received: July 22, 1998
Dear Mr. Johansen:
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 reqistration, listing of devices, qood 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 requlations affecting your device can be found in the Code of Federal Requlations, Title 21, Parts 800 to 895. ਰਾ substantially equivalent determination assumes compliance with -the Current Good Manufacturing Practice requirements, as set forth in the Quality System Requlation (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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Paqe 2 - Mr. Johansen
through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or requlations.
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 requlation (21 CFR Part 801 and additionally 809.10 for in vitro diaqnostic devices), please contact the Office of Compliance at (301) 594-4692. 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"(21CFR 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,
S. Dutman for
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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PREMARKET NOTIFICATION
INDICATIONS FOR USE
510 (k) Number Device Name: Digital Doc, intraoral camera system and
accessories
Indications for Use:
The intraoral camera system, Digital Doc, of Digital Doc, 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 mouth showing the patient results of the dental procedures which the dentist has performed on him.
Concurrence of CDRH, Office of Device Evaluation (ODE)
Susan Rimpis
OR
Division Sign-Off) ivision of Dental, Infection Control, and General Hospital Device 510(k) Number
Prescription Use:
Over-The-Counter-Use: _
(Per 21 CFR 801.109
§ 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.