(30 days)
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Not Found
No
The summary describes a dental alloy material and does not mention any software, algorithms, or AI/ML capabilities.
No
The device is described as an alloy for dental restorations (crowns and bridges), which is a prosthetic or restorative material, not a device used to treat a disease or condition therapeutically.
No
Explanation: The device description indicates it is a dental alloy used for restorations, not for diagnosing medical conditions.
No
The device description clearly states it is a "high Platinum containing Gold base ceramic 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/Indications for Use: The description clearly states that Jel Bios 18 is a ceramic alloy for porcelain to metal restorations in dentistry (crowns, bridges). This is a material used in vivo (within the body) for structural purposes.
- Device Description: The description reinforces its use as a dental restorative material.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens derived from the human body (blood, urine, tissue, etc.) to provide information for diagnosis, monitoring, or treatment.
IVDs are used to perform tests outside the body on biological samples. Jel Bios 18 is a material used inside the body for dental restorations.
N/A
Intended Use / Indications for Use
Jel Bios 18 is a high Platinum containing Gold base ceramic alloy for porcelain to metal restorations. It has light yellow color and due to high Platinum content this alloy offers excellent thermal stability. It is suitable for long span bridges. It is compatible with most of the porcelains available in the market. It can be used for full crown and also for porcelain to metal restoration of single and three to four crown bridges.
Product codes
EJT
Device Description
Jel Bios 18 is a high Platinum containing Gold base ceramic alloy for porcelain to metal restorations. It has light yellow color and due to high Platinum content this alloy offers excellent thermal stability.
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.
Not Found
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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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" around the perimeter. Inside the circle is a stylized symbol featuring three wavy lines that resemble a caduceus or a representation of human figures.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
OCT 21 1999
Mr. Tridib Dasqupta Director R&D J.F. Jelenko & Co. Jelenko Dental Health Products 99 Business Park Drive Armonk, New York 10504
Re: K993152 Trade Name: Jel Bios 18 (Code Name RD-1214) Requlatory Class: II Product Code: EJT September 13, 1999 Dated: Received: September 21, 1999
Dear Mr. Dasgupta:
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 requlations 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) requlation (21 CFR Part 820) and that, through periodic GMP inspections, the Food and Druq 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. Please note: this response to your premarket notification submission does not affect any
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Page 2 - Mr. Dasgupta
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 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 requlation (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,
K. Celotauk
Timothy A. Celotowski
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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. r. c
99 BUSINESS PARK DRIVE. ARMONK. NEW YORK U.S.A. 10504 • (914) 273-8600 F A X: ( 9 1 4 ) 2 7 3 - 9 3 7 9
Page of
novon. 11993152 510(k) Number (if known):
Jel Bios 18 ( Code Name : RD-1214 ) Device Name:
Indications For Use:
Jel Bios 18 is a high Platinum containing Gold base ceramic alloy for porcelain to metal restorations. It has light yellow color and due to high Platinum content this alloy offers excellent thermal stability. It is suitable for long span bridges. It is compatible with most of the porcelains available in the market. It can be used for full crown and also for porcelain to metal restoration of single and three to four crown bridges.
Jridh Dargupta
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Susan Armor
(Division Sign-Off) Division of Dental, Infection Control, and General Hospita 510(k) Number
Prescription Use (Per 21 CFR 801.109)
OR
Over-The-Counter Use