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K Number
K973088
Device Name
PLS-96P
Manufacturer
SOUTHERN DENTAL INDUSTRIES, INC.
Date Cleared
1997-10-03

(46 days)

Product Code
EJJ
Regulation Number
872.3070
Type
Traditional
Panel
DE
Reference & Predicate Devices
N/A
Predicate For
N/A
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use

Silver based alloy dental restorative used in all classes of restorations.

Device Description

PLS-96P Spherical Alloy

AI/ML Overview

I am sorry, but the provided text is a 510(k) clearance letter from the FDA for a dental alloy device (PLS-96P Spherical Alloy). It states that the device is substantially equivalent to legally marketed predicate devices and outlines the general controls and regulations it is subject to.

The document does not contain information about:

  1. Acceptance criteria and reported device performance.
  2. Sample sizes or data provenance for a study.
  3. Number or qualifications of experts for ground truth.
  4. Adjudication methods.
  5. Multi-Reader Multi-Case (MRMC) comparative effectiveness studies or effect sizes for AI assistance.
  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.

Therefore, I cannot fulfill your request based on the provided text.

§ 872.3070 Dental amalgam, mercury, and amalgam alloy.

(a)
Identification. Dental amalgam is a device that consists of a combination of elemental mercury, supplied as a liquid in bulk, sachet, or predosed capsule form, and amalgam alloy composed primarily of silver, tin, and copper, supplied as a powder in bulk, tablet, or predosed capsule form, for the direct filling of carious lesions or structural defects in teeth. This device also includes the individual component devices, mercury and amalgam alloy, when intended to be combined with each other to form dental amalgam.(b)
Classification. Class II (special controls). The special control for this device is FDA's “Class II Special Controls Guidance Document: Dental Amalgam, Mercury, and Amalgam Alloy.”See § 872.1(e) for the availability of this guidance document.