(148 days)
Not Found
Not Found
No
The provided 510(k) summary contains no information about the device description, image processing, or any mention of AI, DNN, or ML.
No
The device description is not found, preventing a determination of whether it is a therapeutic device. The predicate device information does not clarify its function.
No
The provided text lacks specific information about the device's function that would indicate it is used for diagnosis. The "Indications for Use" section refers to an enclosure that is not provided, and there is no description of the device or its capabilities. Without details on how the device operates or what it measures, it cannot be confirmed as a diagnostic device.
Unknown
The provided 510(k) summary is incomplete and lacks a device description, making it impossible to determine if the device is software-only.
Based on the provided information, it is not possible to definitively determine if this device is an IVD.
Here's why:
- The "Intended Use / Indications for Use" section is the most crucial for determining if a device is an IVD. It states "for the indications for use stated in the enclosure". Without the content of this enclosure, we cannot see if the device is intended for the examination of specimens derived from the human body for the purpose of providing information for the diagnosis, monitoring, or treatment of disease or other conditions. This is the core definition of an IVD.
- The other sections are "Not Found". While the absence of information about image processing, AI, anatomical site, etc., might suggest it's less likely to be a complex imaging-based IVD, it doesn't rule out other types of IVDs (e.g., a simple test kit).
To determine if this device is an IVD, you would need to review the "indications for use stated in the enclosure". If those indications involve testing human specimens for diagnostic or related purposes, then it is likely an IVD.
N/A
Intended Use / Indications for Use
Not Found
Product codes
KOJ
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
Not Found
Key Metrics
Not Found
Predicate Device(s)
Not Found
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 872.6080 Airbrush.
(a)
Identification. An airbrush is an AC-powered device intended for use in conjunction with articulation paper. The device uses air-driven particles to roughen the surfaces of dental restorations. Uneven areas of the restorations are then identified by use of articulation paper.(b)
Classification. Class II. The special control for this device is International Electrotechnical Commission's IEC 60601-1-AM2 (1995-03), Amendment 2, “Medical Electrical Equipment—Part 1: General Requirements for Safety.”
0
Image /page/0/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized image of an eagle with three lines forming its body and wings. The eagle is facing to the right. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES . USA" is arranged in a circular pattern around the eagle.
NOV 2 1 2006
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Mr. Don M. Nevin President Buffalo Dental Manufacturing Company, Incorporated 99 Lafayette Drive Syosset, New York 11791
Re: K955573
Trade/Device Name: Optiblast Intraoral Sandblaster Regulatory Class: III Product Code: KOJ Dated: March 18, 1996 Received: March 21, 1996
Dear Mr. Nevin:
This letter corrects our substantially equivalent letter of May 3, 1996.
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 (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 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.
1
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. 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 continue 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), please contact the Office of Compliance at (240) 276-0115. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html
Sincerely vours.
Sylite y. Michael MD
Chiu Lin, Ph.D. Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure