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K Number
K980159
Device Name
OCTYLDENT (2-OCTYL CYANOACRYLATE), 02A01
Manufacturer
CLOSURE MEDICAL CORP.
Date Cleared
1998-04-09

(83 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

Octyldent® is intended for use as an adhesive for the temporary fixing of periodontal polymer or fibers in periodontal pockets.

Device Description

Not Found

AI/ML Overview

The provided text is a 510(k) clearance letter for the Octyldent® (2-octyl cyanoacrylate) device. This type of document primarily confirms that a new medical device is substantially equivalent to a legally marketed predicate device, allowing it to be marketed. It does not typically contain detailed information about acceptance criteria, specific device performance data from a clinical study, or the methodology of such a study.

Therefore,Based on the provided text, I cannot furnish the requested information regarding acceptance criteria and the study that proves the device meets them because this document is a 510(k) clearance letter and does not contain that level of detail.

Specifically, the following information is not present in the provided text:

  1. A table of acceptance criteria and the reported device performance: The document only states the device is "substantially equivalent" to predicate devices for its stated indications for use. It does not provide specific performance metrics or acceptance criteria.
  2. Sample size used for the test set and the data provenance: This information is not included.
  3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: This information is not included.
  4. Adjudication method for the test set: This information is not included.
  5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, and its effect size: This information is not included.
  6. If a standalone performance study was done: This information is not included.
  7. The type of ground truth used: This information is not included.
  8. The sample size for the training set: This information is not included.
  9. How the ground truth for the training set was established: This information is not included.

The document's purpose is to grant clearance for marketing based on substantial equivalence, not to detail the results of performance studies. Such details would typically be found in the 510(k) submission itself, which is not provided here.

§ 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.