LogoFDA 510(k) Search
K Number
K021146
Device Name
D/SENSE 1-STEP
Manufacturer
CENTRIX, INC.
Date Cleared
2002-07-02

(84 days)

Product Code
EJK
Regulation Number
872.3250
Type
Traditional
Panel
DE
Reference & Predicate Devices
N/A
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use

Not Found

Device Description

Not Found

AI/ML Overview

I am sorry, but the provided text is a 510(k) clearance letter from the FDA for a dental device called "D/Sense 1-Step." This document primarily addresses the regulatory approval of the device based on its substantial equivalence to a legally marketed predicate device.

The document does not contain the information requested in your prompt regarding:

  1. A table of acceptance criteria and reported device performance.
  2. Sample size used for the test set and data provenance.
  3. Number and qualifications of experts for ground truth.
  4. Adjudication method.
  5. Multi-reader multi-case (MRMC) comparative effectiveness study details.
  6. Standalone algorithm performance.
  7. Type of ground truth used.
  8. Sample size for the training set.
  9. How ground truth for the training set was established.

This type of information would typically be found in a clinical study report or a more detailed section of the 510(k) submission itself, which is not provided in the given text. The letter only confirms that the FDA reviewed the submission and found the device substantially equivalent.

§ 872.3250 Calcium hydroxide cavity liner.

(a)
Identification. A calcium hydroxide cavity liner is a device material intended to be applied to the interior of a prepared cavity before insertion of restorative material, such as amalgam, to protect the pulp of a tooth.(b)
Classification. Class II.