SMILE WITH CONFIDENCE by LLOYD V. ZIEMENDORF

This document is a 510(k) clearance letter from the FDA for a device called "Smile With Confidence". The letter does not contain information about acceptance criteria or a study proving the device meets them. It primarily states that the device is substantially equivalent to legally marketed predicate devices.

Therefore, I cannot provide the requested information based on the given input. The document does not describe:

A table of acceptance criteria and reported device performance.
Sample size used for the test set or data provenance.
Number of experts used to establish ground truth or their qualifications.
Adjudication method for the test set.
Information about a multi-reader multi-case (MRMC) comparative effectiveness study or any effect size.
Results from a standalone algorithm performance study.
The type of ground truth used.
The sample size for the training set.
How the ground truth for the training set was established.

Summary

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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

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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

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Labels	Values
510(k) Number (if known):	K971002
Device Name:	Smile with Confidence

Indications For Use:

Produ elining More Soft الاست u-S

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEBDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

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)

Regulation Number and Section

§ 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.”