(118 days)
Not Found
Not Found
No
The provided 510(k) summary contains no information about the device description, image processing, AI/ML mentions, or performance studies, making it impossible to determine if AI/ML is incorporated.
No
The only information provided is "Smile with Confidence" under "Intended Use / Indications for Use", which does not indicate any therapeutic intent or medical purpose.
No
The provided information only states "Smile with Confidence" under "Intended Use / Indications for Use", which does not describe a diagnostic purpose. All other fields are marked "Not Found".
Unknown
The provided 510(k) summary is incomplete and lacks crucial information about the device description and its components, making it impossible to determine if it is a software-only medical device.
Based on the provided information, it is highly unlikely that this device is an IVD (In Vitro Diagnostic).
Here's why:
- Lack of Key IVD Indicators: The provided text is completely devoid of any information typically associated with IVDs. IVDs are medical devices used to examine specimens taken from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening.
- "Smile with Confidence" as Intended Use: This phrase is a very general marketing statement and does not describe a diagnostic purpose or a specific medical condition being tested for.
- Missing Technical Details: There is no mention of:
- Specimen type: What is being tested?
- Analyte: What is being measured or detected?
- Methodology: How is the test performed?
- Performance characteristics: Sensitivity, specificity, etc., which are crucial for evaluating the accuracy of an IVD.
- Clinical context: How the results are used in patient care.
Conclusion:
The information provided strongly suggests that this device is not an IVD. The intended use "Smile with Confidence" points towards a consumer product, likely related to oral hygiene or aesthetics, rather than a diagnostic medical device.
N/A
Intended Use / Indications for Use
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Product codes
EHS
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
§ 872.3540 OTC denture cushion or pad.
(a)
Identification. An OTC denture cushion or pad is a prefabricated or noncustom made disposable device that is intended to improve the fit of a loose or uncomfortable denture, and may be available for purchase over-the-counter.(b)
Classification. (1) Class I if the device is made of wax-impregnated cotton cloth that the patient applies to the base or inner surface of a denture before inserting the denture into the mouth. The device is intended to be discarded following 1 day's use. The class I device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 872.9.(2) Class II (special controls) if the OTC denture cushion or pad is made of a material other than wax-impregnated cotton cloth or if the intended use of the device differs from that described in paragraph (b)(1) of this section. 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. The special controls for this device are FDA's:
(i) “Use of International Standard ISO 10993 ‘Biological Evaluation of Medical—Devices Part I: Evaluation and Testing,’ ” and
(ii) “OTC Denture Reliners, Repair Kits, and Partially Fabricated Denture Kits.”
0
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 heads, representing the department's mission to protect the health of all Americans and provide essential human services. The eagle is surrounded by the words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" in a circular arrangement.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Mr. Lloyd V. Ziemendorf ·U.S. Correspondent 6762 Ward Road Niagara Falls, New York 14304-4556
JUL 1 5 1997
K971002 Re : Smile With Confidence Trade Name: III Requlatory Class: Product Code: EHS June 9, 1997 Dated: Received: June 10, 1997
Dear Mr. Ziemendorf:
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 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 The general controls provisions of the Act 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 (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Requlations, Title 21, Parts 800 to 895. ਸ substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirement, as set forth in the Quality System Regulation (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 In addition, FDA may publish further announcements action. 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
1
Page 2 - Mr. Ziemendorf
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 diagnostic devices), please contact the Office of Compliance at (301) 594-4618. 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" (21 CFR 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/dsmamain.html".
Sincerely yours,
Timothy A. Ulatowski
Timo Director Division of Dental, Infection Control and General Hospital Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
Page 1 of 1
| Labels | Values |
|---|---|
| 510(k) Number (if known): | K971002 |
| Device Name: | Smile with Confidence |
Indications For Use:
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(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEBDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
OR
Susan Runner
iDivision Sign-Off) Division of Dental, Infection Control and General Hospital D 510/k) Number
Prescription Use (Per 21 CFR 801. 109) Over-The-Counter Use
(Optional Format 1-2-96)