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K Number
K973370
Device Name
AQUAPLAST PALATAL STENT
Manufacturer
WFR/AQUAPLAST CORP.
Date Cleared
1997-12-02

(85 days)

Product Code
EMA
Regulation Number
872.3275
Type
Traditional
Panel
DE
Reference & Predicate Devices
N/A
Predicate For
N/A
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use

Dressing for use after intraoral palatal surgery.

Device Description

PS Thermoplastic (Aquaplast) Palatal Stent

AI/ML Overview

The provided text is a 510(k) clearance letter from the FDA for a device called "Aquaplast Palatal Stent." This document is a regulatory approval, not a scientific study report. Therefore, it does not contain the detailed information about acceptance criteria or a study proving device performance as requested.

The letter confirms that the device is "substantially equivalent" to devices marketed prior to May 28, 1976. This determination of substantial equivalence is based on the device's indications for use and classification, rather than explicit performance metrics from a controlled study described within this document.

Consequently, I cannot extract the following information from the provided text:

  1. A table of acceptance criteria and the reported device performance: This document does not describe specific performance metrics or acceptance criteria other than "substantial equivalence."
  2. Sample size used for the test set and the data provenance: No study data or test set information is present.
  3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable, as no study is detailed.
  4. Adjudication method: Not applicable.
  5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance: Not applicable. This device is a palatal stent, not an AI-assisted diagnostic tool.
  6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: Not applicable.
  7. The type of ground truth used: Not applicable.
  8. The sample size for the training set: Not applicable.
  9. How the ground truth for the training set was established: Not applicable.

The document is purely administrative, granting marketing clearance based on a regulatory comparison to existing devices, not on the presentation of new performance study data.

§ 872.3275 Dental cement.

(a)
Zinc oxide-eugenol —(1)Identification. Zinc oxide-eugenol is a device composed of zinc oxide-eugenol intended to serve as a temporary tooth filling or as a base cement to affix a temporary tooth filling, to affix dental devices such as crowns or bridges, or to be applied to a tooth to protect the tooth pulp.(2)
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 § 872.9.(b)
Dental cement other than zinc oxide-eugenol —(1)Identification. Dental cement other than zinc oxide-eugenol is a device composed of various materials other than zinc oxide-eugenol intended to serve as a temporary tooth filling or as a base cement to affix a temporary tooth filling, to affix dental devices such as crowns or bridges, or to be applied to a tooth to protect the tooth pulp.(2)
Classification. Class II.