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K Number
K043504
Device Name
PALAIMPACT
Manufacturer
HERAEUS KULZER, INC.
Date Cleared
2005-01-28

(39 days)

Product Code
EBI
Regulation Number
872.3760
Type
Traditional
Panel
DE
Reference & Predicate Devices
N/A
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use

PalaImpact is a heat curing, high-impact denture acrylic resin for the fabrication of full and partial dentures. PalaImpact is also used for fixed and removable prosthetics devices.

Device Description

Not Found

AI/ML Overview

This document is a 510(k) clearance letter for a dental device, not a study report. Therefore, it does not contain the information required to answer the questions about acceptance criteria, study design, and performance. The letter simply states that the FDA has found the device, "Palaimpact®", to be substantially equivalent to legally marketed devices based on the information provided in the premarket notification.

Here's why the requested information cannot be extracted:

  • Acceptance Criteria and Device Performance: The letter does not list specific performance metrics or acceptance criteria for the device (e.g., strength, durability, biocompatibility) nor does it report any study results against such criteria.
  • Sample Size, Data Provenance, Experts, Adjudication, MRMC, Standalone Performance, Ground Truth, Training Set: These are all details typically found in a clinical or performance study report, which is not what this document is. The 510(k) process relies on demonstrating substantial equivalence, which can sometimes involve comparing the new device's specifications to those of an already cleared predicate device, or presenting data from bench testing or limited clinical studies. However, the details of those studies are not typically included in the FDA's clearance letter itself.

In summary, this document is an FDA clearance letter and not a scientific study report. As such, it does not provide the specific technical details of the device's performance evaluation.

§ 872.3760 Denture relining, repairing, or rebasing resin.

(a)
Identification. A denture relining, repairing, or rebasing resin is a device composed of materials such as methylmethacrylate, intended to reline a denture surface that contacts tissue, to repair a fractured denture, or to form a new denture base. This device is not available for over-the-counter (OTC) use.(b)
Classification. Class II.