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K Number
K972532
Device Name
AALBA GOLD SOLDER
Manufacturer
AALBA DENT, INC.
Date Cleared
1997-08-15

(39 days)

Product Code
EJT
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

This device is a "yellow-gold" colored, soldering alloy for use in the construction and repair of crown and bridge dental prosthetic devices. According to 21 CFR Ch. 1 (4-1-89 Ed.) Part 872. the classification name for this device is Gold Based Alloy and Precious Metal Alloys for Clinical Use, a Class II device.

Device Description

"yellow-gold" colored, soldering alloy

AI/ML Overview

This is a 510(k) premarket notification letter from the FDA regarding a "Yellow-Gold" Colored, Soldering Alloy (Trade Name: Aalba Gold Solder) from Aalba Dent, Incorporated. This document is a clearance letter, not a study report, so it does not contain the specific information requested about acceptance criteria and device performance studies.

Therefore, I cannot provide the requested information:

  1. A table of acceptance criteria and the reported device performance
  2. Sample size used for the test set and the data provenance
  3. Number of experts used to establish the ground truth for the test set and their qualifications
  4. Adjudication method for the test set
  5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done
  6. If a standalone performance study was done
  7. The type of ground truth used
  8. The sample size for the training set
  9. How the ground truth for the training set was established

This document only states that the FDA has determined the device is substantially equivalent to legally marketed predicate devices, which allows it to proceed to the market. It references compliance with general controls provisions and Good Manufacturing Practice requirements, but does not detail specific performance studies conducted by the manufacturer for this clearance.

§ 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.