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K Number
K040179
Device Name
CONTINUM
Manufacturer
AALBA DENT, INC.
Date Cleared
2004-03-03

(36 days)

Product Code
EJH
Regulation Number
872.3710
Type
Traditional
Panel
DE
Reference & Predicate Devices
N/A
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use

This device is a non precious, nickel-chromium-molybdenum-beryllium based alloy for use in the construction of cast ceramic bonded crown and bridge dental restorations.

Device Description

This device is a non precious, nickel-chromium-molybdenum-beryllium based alloy.

AI/ML Overview

I apologize, but the provided text does not contain the information requested to describe the acceptance criteria and the study that proves the device meets those criteria. The document is a 510(k) premarket notification letter from the FDA to Aalba Dent, Incorporated for their Continum™ dental alloy. It primarily confirms that the device has been reviewed and determined to be substantially equivalent to legally marketed predicate devices.

The document does not include:

  1. A table of acceptance criteria and reported device performance.
  2. Details on sample sizes, data provenance, or retrospective/prospective study design.
  3. Information on the number or qualifications of experts used for ground truth.
  4. Adjudication methods.
  5. Information about multi-reader multi-case (MRMC) comparative effectiveness studies or human reader improvement with AI.
  6. Data on standalone algorithm performance.
  7. The type of ground truth used (e.g., pathology, outcomes).
  8. The sample size for the training set.
  9. How the ground truth for the training set was established.

The letter only states the device name (Continum™), its regulation name (Base Metal Alloy), regulatory class (Class II), and its intended use (a non-precious, nickel-chromium-molybdenum-beryllium based alloy for use in the construction of cast ceramic bonded crowns and bridges). It indicates that the FDA has determined the device to be substantially equivalent.

§ 872.3710 Base metal alloy.

(a)
Identification. A base metal alloy is a device composed primarily of base metals, such as nickel, chromium, or cobalt, that is intended for use in fabrication of cast or porcelain-fused-to-metal crown and bridge restorations.(b)
Classification. Class II (special controls). The special control for this device is FDA's “Class II Special Controls Guidance Document: Dental Base Metal Alloys.” The device is 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.