(33 days)
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No
The 510(k) summary describes a dental alloy, which is a material, not a software-driven device. There are no mentions of AI, ML, image processing, or performance studies related to algorithmic analysis.
No
The device is described as a "Crown & Bridge alloy" used for making dental restorations like crowns, inlays, and bridges. While these are used in healthcare, they are restorative materials, not therapeutic devices intended to treat or cure a disease or condition.
No
The device description states it is a "Crown & Bridge alloy," which is a material used for restorative work, not for diagnosing conditions.
No
The device description clearly states it is a "Crown & Bridge alloy," which is a physical material, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use describes a material for dental restorations (crowns, bridges, etc.). This is a device used in the body or to create a device for use in the body, not a test performed on a sample taken from the body to diagnose a condition.
- Device Description: The description confirms it's a dental alloy.
- Lack of IVD Characteristics: The document lacks any mention of typical IVD elements such as:
- Analyzing biological samples (blood, urine, tissue, etc.)
- Detecting or measuring substances in those samples
- Providing diagnostic information about a patient's health status
Therefore, this device falls under the category of a dental material or prosthetic device, not an In Vitro Diagnostic.
N/A
Intended Use / Indications for Use
Page 1 of 1
510(k) Number: K012303
Device Name (s): Jel-20
This is a white Type III Crown & Bridge alloy for single & ¾ crowns, inlays, veneer crowns, and short span bridges.
Product codes
EJS
Device Description
Jel-20 is described as a white Type III Crown & Bridge alloy.
Mentions image processing
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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
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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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§ 872.3060 Noble metal alloy.
(a)
Identification. A noble metal alloy is a device composed primarily of noble metals, such as gold, palladium, platinum, or silver, that is intended for use in the fabrication of cast or porcelain-fused-to-metal crown and bridge restorations.(b)
Classification. Class II (special controls). The special control for these devices is FDA's “Class II Special Controls Guidance Document: Dental Noble Metal Alloys.” The devices are exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 872.9. See § 872.1(e) for availability of guidance information.
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DEPARTMENT OF HEALTH & HUMAN SERVICES
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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
AUG 2 2 2001
Mr. Raphael Judkins Manager of Regulatory Affairs J.F. Jelenko & Company, Incorporated 99 Business Park Drive Armonk, New York 10504
K012303 Re : Trade/Device Name: JEL-20 Regulation Number:872.3060 Regulatory Class: II Product Code: EJS Dated: July 19, 2001 Received: July 20, 2001
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 legally marketed predicate 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 of the Act. The general controls provisions 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 requlations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Requlation (QS) for Medical Devices: General requlation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP requlation may result in regulatory
1
Page 2 - Mr. Judkins
In addition, FDA may publish further announcements action. concerning your device in the Federal Register. 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 requlations.
This letter will allow you to begin marketing your device as described in your 510 (k) premarket notification. The FDA finding of 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" (21CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsma/dsmamain.html".
Sincerely yours,
Olin S. L/on
Timothy A. Ulatowsk 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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Heraeus Kulzer, Inc. 99 Business Park Drive Armonk, NY 10504 (914) 273-8600
INDICATIONS FOR USE
Page 1 of 1
510(k) Number: K012303
Device Name (s): Jel-20
This is a white Type III Crown & Bridge alloy for single & ¾ crowns, inlays, veneer crowns, and short span bridges.
MACCaff La MSR
(Division Sign-Off) Division of Dental, Infection Control, and General Hospital Devices 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
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