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K Number
K052073
Device Name
FUTURAPRESS LT, N AND HP, FUTURAJET, FUTURASELF, FUTURAGEN AND FUTURACRYL 2000
Manufacturer
SCHUTZ-DENTAL GMBH
Date Cleared
2005-10-26

(86 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

Cold-curing, methyl methacrylate resin for adding the saddles to cobalt chrome denture bases, repairs, additions and relines, and relines. Cold-curing, methyl methacrylate resin for the completion of full and partial dentures. Cold-curing, methyl methacrylate resin for adding saddles to cobalt chrome dentures bases, repairs, additions and other repairs. Cold-curing, methyl methacrylate resin intended specifically for injection moulding techniques (e. g. Unipress). Cold-curing repair resin for additions, replacing teeth and relining dentures. Heat-curing, methyl methacrylate resin for fabricating partial and full dentures using flasks and clamps or injection moulding systems. Heat-curing, methyl methacrylate resin, with liquid phase, for adding the saddles to cobalt chrome denture bases and other repairs.

Device Description

Not Found

AI/ML Overview

I am sorry, but the provided text is a letter from the FDA regarding a 510(k) premarket notification for several dental resins. It confirms that the devices are substantially equivalent to legally marketed predicate devices.

The document does not contain any information about:

  • Acceptance criteria table or reported device performance for a study.
  • Sample sizes used for test sets or data provenance.
  • Number or qualifications of experts for ground truth establishment.
  • Adjudication methods.
  • Multi-reader multi-case (MRMC) comparative effectiveness studies.
  • Standalone (algorithm only) performance studies.
  • Type of ground truth used.
  • Sample size for training sets.
  • How ground truth for training sets was established.

Therefore, I cannot fulfill your request for this information based on the provided text.

§ 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.