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K Number
K013809
Device Name
D.SIGN 59
Manufacturer
IVOCLAR VIVADENT, INC.
Date Cleared
2002-02-07

(84 days)

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

d.SIGN 59 alloy intended to be used for onlay, ¾ crows, telescope crowns, conus crowns, posts, short and long span bridges, PFM crowns.

Device Description

d.SIGN 59 alloy

AI/ML Overview

I am sorry, but the provided text does not contain any information about acceptance criteria or a study that proves a device meets those criteria. The document is an FDA 510(k) clearance letter for a dental alloy named "d.Sign 59," confirming its substantial equivalence to a legally marketed predicate device.

Therefore, I cannot provide the requested information, including:

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

§ 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.