JELTEMP

• 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: Dental
• Reference & Predicate Devices: N/A
• Predicate For: N/A

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.

Summary

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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circle with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract image of an eagle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JUN 23 1999

Mr. Raphael Judkins Manager of Quality Systems Administration J.F. Jelenko and Company 99 Business Park Drive Armonk, New York 10504

Re : K991564 JelTemp™ Trade Name: II Requlatory Class: EBG Product Code: Dated: May 4, 1999 Received: May 5, 1999

Dear Mr. Judkins:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act). You may, therefore, market the device, subject to the general controls provisions The general controls provisions of the Act of the Act. include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.

If your device is classified (see above) into either class II (Special Controls) or class III (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Requlations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Good Manufacturing Practice for Medical Devices: General (GMP) regulation (21 CFR Part 820) and that, through periodic GMP inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP requlation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register.

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Page 2 - Mr. Judkins

Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

This letter will allow you to begin marketing your device as described in your 510(k) premarket notification. The FDA acborized is substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at [phone]. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number [phone] or [phone] or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".

Sincerely yours,

Timothy A. Ulatowski

Director Division of Dental, Infection Control, and General Hospital Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Image /page/2/Picture/0 description: The image shows a sequence of characters and numbers. The sequence starts with the letter 'K', followed by the numbers '991564'. The characters and numbers are written in a bold, sans-serif font, and they appear to be handwritten or drawn with a thick marker.

Image /page/2/Picture/1 description: The image shows the logo for Jelenko Dental Health Products. The logo is in black and white, with the word "JELENKO" in large, bold letters at the top. Below that, in smaller letters, are the words "DENTAL HEALTH PRODUCTS" and "ISO 9001 REGISTERED". The logo is simple and professional-looking.

SUSINESS PARK DRIVE, ARMONK, NEW YORK 10504 USA http://www.jelenko.com

[phone] PHONE: [phone]

INDICATIONS FOR USE

Page 1 of 1

510(k) Number: K991564

Device Name:______JelTemp™

JelTemp is for the fabrication of long term temporaries using JelTemp Shell The Dentist sends an impression of the prepared teeth to the lab. Teeth. 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.

Susan Runys

(Division Sign-O Division of Dental, Infection and General Hospital Dev 510(k) Number

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

CONCURRENCE OF CHRD, OFFICE OF DEVICE EVALUATION (OED)

Prescription use (Per 21 CFR 801.109)

OR

Over-The-Counter Use ------

Regulation Number and Section

§ 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.