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K Number
K051952
Device Name
EUGENONE
Manufacturer
SCIENTIFIC PHARMACEUTICALS, INC.
Date Cleared
2005-09-07

(51 days)

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

Eugenone is a eugenol-free temporary cement used in the placement of temporary or temporary placement of permanent prostheses.

Device Description

Eugenone is a eugenol-free temporary cement.

AI/ML Overview

This document is a 510(k) premarket notification decision letter from the FDA for a dental cement named "Eugenone." It's not a study report, and therefore, it does not contain the detailed information requested regarding acceptance criteria and performance studies for a device.

The letter explicitly states: "We have reviewed your Section 510(k) premarket notification of intent to market the device... and have determined that this 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..."

This indicates that the device was cleared based on substantial equivalence to existing predicate devices, rather than through a new clinical performance study that would generate the kind of data you're asking for.

Therefore, I cannot provide the requested information for the following reasons:

  1. Acceptance criteria and reported device performance: This document does not specify formal acceptance criteria for a new study, nor does it report on the device's performance against such criteria. The clearance is based on equivalence.
  2. Sample size, data provenance: No new study data is provided, so these details are not available.
  3. Number of experts, qualifications, adjudication method, ground truth type: These are all details related to a clinical study establishing ground truth, which is not present in this regulatory clearance document.
  4. MRMC comparative effectiveness study: This is not mentioned as part of the review for substantial equivalence.
  5. Standalone performance: Not applicable as no new performance study is detailed.
  6. Training set sample size and ground truth establishment: Not applicable as this is not a study report with distinct training and test sets.

In summary, the provided document is a regulatory clearance letter, not a technical report detailing a performance study.

§ 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.