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K Number
K123929
Device Name
BEGOPAL+
Manufacturer
BEGO BREMER GOLDSCHLAEGEREI WILH. HERBST GMBH & CO
Date Cleared
2013-03-14

(84 days)

Product Code
EJH
Regulation Number
872.3710
Type
Abbreviated
Panel
DE
Reference & Predicate Devices
K032136
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use

BegoPal+ is a porcelain-fused-to-metal (PFM) noble alloy. It is suitable for fabrication of crown and bridge restorations. BegoPal+ is available as powder and is processed by selective laser melting.

Device Description

BegoPal+ is a palladium containing cobalt-chromium alloy for fabrication of porcelain fused to metal dental restorations. BegoPal+ is available as powder and is processed by selective laser melting.

AI/ML Overview

This appears to be a 510(k) premarket notification document for a dental alloy, BegoPal+. This document does not contain information about software, or a device that would require the kind of performance study details (acceptance criteria, training/test sets, expert adjudication, MRMC studies) you've requested.

The document discusses:

  • Device Description: BegoPal+ is a palladium-containing cobalt-chromium alloy for dental restorations.
  • Processing: It's processed by selective laser melting (SLM).
  • Indications for Use: Porcelain-fused-to-metal (PFM) noble alloy for crown and bridge restorations.
  • Predicate Devices: Lists similar alloys (Wirobond C, Wirobond C+, Callisto CP+).
  • Comparison to Predicate Devices: States substantial equivalence based on indications, technical parameters, and biocompatibility, despite differences in product shape, processing, and material composition.
  • Testing: Mentions test results according to ISO 22674, ISO 9693-1, ISO 10271, and ISO 10993 which demonstrate safety and effectiveness.

Therefore, it is impossible to extract the information you requested from this document as it pertains to a physical material, not a software or AI-driven medical device.

If you are looking for an example of a 510(k) submission for a software or AI device, you would need a different document.

§ 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.