(15 days)
Not Found
Not Found
No
The provided 510(k) summary contains no mention of AI, ML, image processing, or any other technology typically associated with AI/ML in medical devices. The intended use and device description (though not found) point towards a device for dental cleaning and polishing, which are generally mechanical or chemical processes.
Yes
The device is intended to relieve dental hypersensitivity and manage tooth sensitivity, which are therapeutic effects.
No
The device is described as being used for cleaning, polishing, relieving hypersensitivity, and managing tooth sensitivity following procedures, all of which are treatment-oriented rather than diagnostic.
No
The provided 510(k) summary describes a device used for "cleaning and polishing procedures" and "relieving dental hypersensitivity." These are physical actions typically performed by a hardware device (like a dental handpiece or polishing tool) and not solely by software. The lack of a "Device Description" further prevents confirmation of a software-only nature.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use describes a device used for cleaning, polishing, and relieving dental hypersensitivity within the mouth as part of a professional dental procedure. This is a direct interaction with the patient's body, not an analysis of samples taken from the body.
- Lack of IVD Characteristics: The description does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological samples (blood, urine, tissue, etc.)
- Providing information about a disease or condition based on sample analysis
- Using reagents or assays
IVDs are devices used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device's function is entirely external to that definition.
N/A
Intended Use / Indications for Use
To be used for cleaning and polishing procedures as part of professionally administered prophylaxis treatment. To relieve dental hypersensitivity and for the management of tooth sensitivity following in-office bleaching procedures, ultrasonic, hand scaling or root planning.
Product codes
EJR
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
§ 872.6030 Oral cavity abrasive polishing agent.
(a)
Identification. An oral cavity abrasive polishing agent is a device in paste or powder form that contains an abrasive material, such as silica pumice, intended to remove debris from the teeth. The abrasive polish is applied to the teeth by a handpiece attachment (prophylaxis cup).(b)
Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 872.9.
0
Image /page/0/Picture/2 description: The image shows the seal for the Department of Health and Human Services. The seal is circular, with the words "DEPARTMENT OF HEALTH AND HUMAN SERVICES, USA" written around the edge. In the center of the seal is an abstract image of a bird-like figure. The figure is composed of three curved lines that resemble the wings and body of a bird.
APR 1 2 2007
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Mr. Terry L. Joritz-Lyons Director, Regulatory Affairs & Quality Assurance GC America, Incorporated 3737 West 127th Street Alsip, Illinois 60803
Re: K070854
Trade/Device Name: GC MI Paste Plus Regulation Number: 872.6030 Regulation Name: Oral Cavity Abrasive Polishing Agent Regulatory Class: I Product Code: EJR Dated: March 21, 2007 Received: March 28, 2007
Dear Mr. Joritz-Lyons:
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.
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Page 2 - Mr. Joritz-Lyons
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 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), 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 (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours.
Supa Runner
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
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Indications for Use
510(k) Number (if known): ַ
11070854
Device Name:
MI Paste Plus
Indications for Use:
To be used for cleaning and polishing procedures as part of professionally administered prophylaxis treatment. To relieve dental hypersensitivity and for the management of tooth sensitivity following in-office bleaching procedures, ultrasonic, hand scaling or root planning.
Prescription Use (21 CFR Part 801 Subpart D) AND/OR
Over-The-Counter Use (21 CFR Part 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Susan Romano
(k) Number: 100 70854
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