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K Number
K971002
Device Name
SMILE WITH CONFIDENCE
Manufacturer
LLOYD V. ZIEMENDORF
Date Cleared
1997-07-15

(118 days)

Product Code
EHS
Regulation Number
872.3540
Type
Traditional
Panel
DE
Reference & Predicate Devices
N/A
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use

Produ elining More Soft الاست u-S

Device Description

Not Found

AI/ML Overview

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:

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

§ 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.”