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K Number
K984451
Device Name
D-SIGN I (R&D PROJECT DW263 #24)
Manufacturer
IVOCLAR NORTH AMERICA, INC.
Date Cleared
1999-01-19

(35 days)

Product Code
EJS
Regulation Number
872.3060
Type
Traditional
Panel
DE
Reference & Predicate Devices
N/A
Predicate For
N/A
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use

Indications for Use: D-Sign is to be used with conventional feldpathic porcelains. Also recommended for 3/4 crowns, telescop crowns, conus porceration indo roomments, short and long span bridges, PFM crowns.

Device Description

Not Found

AI/ML Overview

The provided text is a 510(k) premarket notification letter from the FDA to Ivoclar North America, Incorporated, regarding their device "D-Sign I". This document confirms that the device is substantially equivalent to a legally marketed predicate device.

However, the letter does not contain any information about acceptance criteria for device performance, nor details of any study conducted to prove the device meets such criteria. It's a regulatory approval document confirming substantial equivalence, not a scientific study report.

Therefore, I cannot provide the requested information from the given text. The document states:

  • Device Name: D-Sign I
  • 510(k) Number: K984451
  • Indications for Use: To be used with conventional feldpathic porcelains. Also recommended for 3/4 crowns, telescop crowns, conus porceration indo roomments, short and long span bridges, PFM crowns.

But it does not include:

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

This is a regulatory letter of approval based on substantial equivalence, not a detailed technical report of device performance testing.

§ 872.3060 Noble metal alloy.

(a)
Identification. A noble metal alloy is a device composed primarily of noble metals, such as gold, palladium, platinum, or silver, that is intended for use in the fabrication of cast or porcelain-fused-to-metal crown and bridge restorations.(b)
Classification. Class II (special controls). The special control for these devices is FDA's “Class II Special Controls Guidance Document: Dental Noble Metal Alloys.” The devices are exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 872.9. See § 872.1(e) for availability of guidance information.