(79 days)
The ME-15 Intraoral Camera use only for photographing from a full mouth to a signal tooth. The ME-15 is not intended for any other use.
Intraoral Camera ME-15
The provided text does not contain information about acceptance criteria or a study proving device performance for the "Intraoral Camera ME-15." The document is a 510(k) premarket notification clearance letter from the FDA, indicating that the device has been deemed "substantially equivalent" to legally marketed predicate devices.
This type of FDA clearance relies on demonstrating substantial equivalence, not necessarily on new studies proving acceptance criteria for performance metrics. Therefore, the requested information elements cannot be extracted from this document.
The document states:
- Trade/Device Name: Intraoral Camera ME-15
- Regulation Name: Dental Operative Unit and Accessories
- Indications For Use: The ME-15 Intraoral Camera is for photographing from a full mouth to a single tooth. It is not intended for any other use.
To fulfill the request regarding acceptance criteria and performance study, the original 510(k) submission document would be needed, which is not provided here.
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three stripes forming its body and wings. The eagle is enclosed in a circle, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is written around the circle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
APR 1 1 2002
Mr. David Abelda President DENT Corporation Research & Development 7-11 South Broadway White Plains, New York 10601
Re: K020206
Trade/Device Name: Intraoral Camera ME-15 Regulation Number: 872.6640 Regulation Name: Dental Operative Unit and Accessories Regulatory Class: I Product Code: EIA Dated: January 18, 2002 Received: January 22, 2002
Dear Mr. Abelda :
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 Amendments, 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 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 (PMA), 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 898. In addition. FDA may publish 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. Abelda
You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation 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 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 21 CFR Part 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" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers, International and Consumer 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.
Timothy Ulatowski
Timo 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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Page 2 of 2
KO 20 206 510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________
Device Name: (dTBACRAL CAMERA
Indications For Use:
The ME-15 Intraoral Camera use only for photographing from a full mouth to a signal tooth.
The ME-15 is not intended for any other use.
(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)
OR
Over-The-Counter Use_
(Optional Format: 1-2-96)
Suze Perino
(Division Sign-Off) Division of Dental, Infection Control, and General Hospital De 510(k) Number _
§ 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.