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K Number
K991564
Device Name
JELTEMP
Manufacturer
J.F. JELENKO & CO., INC.
Date Cleared
1999-06-23

(49 days)

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

JelTemp is for the fabrication of long term temporaries using JelTemp Shell Teeth. The Dentist sends an impression of the prepared teeth to the lab. Models are powed from the impression, mounted and articulated. The technician preps models. JelTemp shell teeth are selected in the proper shade for the preped abutments.

Device Description

JelTemp™

AI/ML Overview

After a thorough review of the provided document, the requested information regarding acceptance criteria and a study proving device performance is not present.

This document is a 510(k) clearance letter from the FDA to J.F. Jelenko and Company for their device, JelTemp™. The letter confirms that based on the Section 510(k) notification, the device is substantially equivalent to a legally marketed predicate device.

The clearance letter primarily addresses:

  • The legal basis for marketing the device (substantial equivalence).
  • Applicable regulations (general controls, GMP).
  • Contact information for further regulatory inquiries.
  • Basic device information (trade name, regulatory class, product code, indications for use).

It specifically does not include:

  1. A table of acceptance criteria or reported device performance.
  2. Details about sample sizes for test sets, data provenance, or expert qualifications.
  3. Information on adjudication methods, MRMC studies, or standalone algorithm performance.
  4. The type of ground truth used, training set sample size, or how ground truth for training was established.

The "Indications for Use" section briefly describes the purpose of JelTemp™ (fabrication of long-term temporaries using JelTemp Shell Teeth) and the general workflow, but it does not delve into performance metrics or study specifics.

Therefore, I cannot fulfill the request to describe the acceptance criteria and the study proving the device meets them based on the provided text.

§ 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.