(79 days)
Not Found
Not Found
No
The summary explicitly states "Mentions AI, DNN, or ML: Not Found" and the device description and intended use are limited to basic intraoral photography.
No
The device is described as an intraoral camera used for photographing teeth and the mouth, and its intended use explicitly states "not intended for any other use." This indicates it's a diagnostic imaging tool, not a therapeutic device.
No
The device's intended use is solely for "photographing from a full mouth to a signal tooth," with no mention of diagnosing conditions.
No
The device description explicitly states "Intraoral Camera ME-15," which is a hardware device used for photographing. The summary does not mention any software component as the primary or sole function.
Based on the provided information, the ME-15 Intraoral Camera is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is solely for "photographing from a full mouth to a signal tooth." This describes a device used for capturing images of the inside of the mouth.
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body (like blood, urine, tissue) to detect diseases, conditions, or infections. The ME-15 does not perform any such tests on biological samples.
- Device Description: The description simply states "Intraoral Camera ME-15," which aligns with a device used for imaging the inside of the mouth.
- Lack of IVD-related information: The provided information does not mention any analysis of biological samples, diagnostic testing, or any other activities typically associated with IVDs.
Therefore, the ME-15 Intraoral Camera is a medical device used for imaging, but it does not fit the definition of an In Vitro Diagnostic.
N/A
Intended Use / 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.
Product codes
EIA
Device Description
Not Found
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
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)
Not Found
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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
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.
1
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 _