(49 days)
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Not Found
No
The summary does not mention AI, ML, image processing, or any other technology typically associated with AI/ML in medical devices. The description focuses on fabrication of temporaries using pre-formed shells.
No
The device is used for the "fabrication of long term temporaries" which are dental prosthetics, not for treating a disease or condition. Its purpose is to create a component for dental restoration.
No
Explanation: The intended use of JelTemp is for fabrication, not diagnosis. It creates "long term temporaries" using "JelTemp Shell Teeth," which is a production or fabrication process.
No
The description focuses on the fabrication of physical dental temporaries using "JelTemp Shell Teeth," implying a physical product or process, not solely software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for the "fabrication of long term temporaries using JelTemp Shell Teeth." This describes a process for creating a dental restoration, not a diagnostic test performed on a biological sample.
- Device Description: The device is described as "JelTemp™," which is a material or system used in the fabrication process.
- Lack of IVD Characteristics: The description does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological samples (blood, urine, tissue, etc.)
- Detecting or measuring substances in biological samples
- Providing information for the diagnosis, monitoring, or treatment of a disease or condition based on analysis of biological samples.
The device appears to be a dental material or system used in a restorative procedure, which falls under the category of medical devices but not specifically In Vitro Diagnostics.
N/A
Intended Use / Indications for 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.
Product codes
EBG
Device Description
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
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Indicated Patient Age Range
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Intended User / Care Setting
Dentist, Lab technician
Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
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Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
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Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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§ 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.
0
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.
1
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 (301) 594-4692. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. 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 (800) 638-2041 or (301) 443-6597 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
(800) 431-1785 PHONE: (914) 273-8600
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 ------