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K Number
K971927
Device Name
HI DENSE TC
Manufacturer
SHOFU DENTAL CORP.
Date Cleared
1997-06-30

(34 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

HI DENSE TC is a glass ionomer sliver reinforced restorative dental product. It is indicated for use in:

  1. Class I and II cavities in deciduous teeth.
  2. Repair of amalgam restored teeth when either tooth or restoration has fractured.
  3. Class I and II cavities in selected permanent teeth.
  4. Lining under amalgam and posterior composite restorations.
  5. In other classes of cavity where radiopacity rather than aesthetics is a prime requirement.
  6. As a core build-up material under crowns.
  7. On the root surfaces for locating overdentures.
  8. Long term temporary replacements for cusp(s).
  9. Repair to crown margins.
Device Description

HI DENSE TC is a glass ionomer sliver reinforced restorative dental product.

AI/ML Overview

I apologize, but the provided text is a letter from the FDA regarding a 510(k) premarket notification for a dental product called "HI DENSE TC". This document primarily focuses on the FDA's decision of substantial equivalence and does not contain information about acceptance criteria or a study that proves the device meets those criteria.

Therefore, I cannot provide the requested information about:

  1. A table of acceptance criteria and the reported device performance
  2. Sample sized used for the test set and the data provenance
  3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
  4. Adjudication method for the test set
  5. If a multi reader multi case (MRMC) comparative effectiveness study was done, and its effect size
  6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
  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

The letter confirms that the device "HI DENSE TC" is a glass ionomer silver reinforced restorative dental product and lists its indications for use. It also mentions that the device is substantially equivalent to legally marketed predicate devices. However, it does not describe the specific performance characteristics of the device or any studies conducted to evaluate them against acceptance criteria.

§ 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.