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K Number
K013869
Device Name
SR IVOCRON
Manufacturer
IVOCLAR VIVADENT, INC.
Date Cleared
2002-08-28

(280 days)

Product Code
EBG
Regulation Number
872.3770
Type
Traditional
Panel
DE
Reference & Predicate Devices
N/A
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use

Cold technique: With the Cold Liquid, SR Ivocron may be used for temporaries, securing ground denture teeth, and repair of PMMA.

Hot technique: When used with the Hot Liguid, this technique may be used for temporaries and inexpensive crowns and bridges. For crowns and bridges, SR lvocron must be layered over a metal framework.

Press (flasking) technique: For the press technique, SR Ivocron is mixed with the Press Liquid and may be used for temporaries and inexpensive crowns and bridges. For crowns and bridges, the material must be pressed over a metal framework.

Device Description

Not Found

AI/ML Overview

I am sorry, but based on the provided text, there is no information about the acceptance criteria or a study proving the device meets those criteria. The document is a 510(k) premarket notification letter from the FDA regarding "SR Ivocron," which is a dental material. It states that the device is substantially equivalent to legally marketed predicate devices, allowing it to proceed to market.

The document discusses:

  • The device name, regulation numbers, and product codes.
  • The legal basis for market clearance (substantial equivalence to a predicate device).
  • General controls provisions of the Act that apply to the device.
  • Indications for Use for the SR Ivocron material (cold technique, hot technique, press (flasking) technique).

However, it does not include any details on:

  1. A table of acceptance criteria and reported device performance.
  2. Sample sizes or data provenance for any studies.
  3. Number or qualifications of experts for ground truth establishment.
  4. Adjudication methods.
  5. Multi-reader multi-case (MRMC) comparative effectiveness studies.
  6. Standalone algorithm performance.
  7. Type of ground truth used.
  8. Sample size for training sets.
  9. How ground truth for training sets was established.

This document is a regulatory clearance letter, not a study report or a detailed performance validation.

§ 872.3770 Temporary crown and bridge resin.

(a)
Identification. A temporary crown and bridge resin is a device composed of a material, such as polymethylmethacrylate, intended to make a temporary prosthesis, such as a crown or bridge, for use until a permanent restoration is fabricated.(b)
Classification. Class II.