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K Number
K152981
Device Name
JET SET 4 DENTURE REPAIR RESIN
Manufacturer
LANG DENTAL MANUFACTURING COMPANY, INC
Date Cleared
2016-09-02

(329 days)

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

Jet Set 4 Denture Repair Resin is intended for the manufacture, repair, rebasing, and relining of removable acrylic prosthetic devices (i.e. full and partial dentures). Jet Set 4 Denture Repair Resin is for prescription use only.

Device Description

Not Found

AI/ML Overview

The provided text is a U.S. FDA 510(k) clearance letter for a medical device called "Jet Set 4 Denture Repair Resin." This document primarily focuses on regulatory approval and does not contain information about acceptance criteria, device performance studies, sample sizes, expert qualifications, or ground truth methodologies as typically found in a clinical study report or a premarket approval (PMA) application.

Therefore, I cannot provide the requested information based on the input text. The document states:

  • Trade/Device Name: Jet Set 4 Denture Repair Resin
  • Regulation Number: 21 CFR 872.3760
  • Regulation Name: Denture relining, repairing, or rebasing resin
  • Regulatory Class: Class II
  • Product Code: EBI
  • Intended Use: For the manufacture, repair, rebasing, and relining of removable acrylic prosthetic devices (i.e. full and partial dentures). For prescription use only.

The letter explicitly states, "We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent...". This indicates that the device was cleared based on substantial equivalence to a predicate device, which often involves comparison to existing device performance and safety profiles rather than a new standalone clinical efficacy or performance study.

To answer your request, a different type of document, such as a summary of safety and effectiveness data (SSED) for a PMA, or a clinical study report, would be necessary.

§ 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.