(31 days)
Not Found
None
No
The summary describes a dental alloy material and its intended use, with no mention of software, algorithms, or any technology related to AI or ML.
No
The device is a dental alloy used for fabricating crowns and bridges, which are restorative devices, not therapeutic devices that treat a disease or condition.
No.
The device description clearly states its use for "porcelain to metal restorations" and "fabrication of single units and all bridge work including single and three or four crowns," which indicates it is a restorative material used for treatment, not for diagnosis.
No
The device description clearly indicates it is a dental 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 is for creating dental restorations (crowns and bridges) for patients. This is a direct application within the body, not for testing samples taken from the body.
- Device Description: The description details a material used to fabricate a physical dental device. It doesn't describe a test, reagent, or instrument used to analyze biological samples.
- 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.)
- Providing diagnostic information
- Using reagents or assays
- Measuring biomarkers
Therefore, this device falls under the category of a dental material used for fabrication, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
High Gold and Platinum containing ceramic alloy for porcelain to metal restorations. It is Palladium, Silver and copper free dental alloy with less than 2.0 % base metal. Jel bios 10 is a rich gold color hard gold base alloy with high yield strength and thermal stability. It is compatible with a wide range of porcelain available in the market. It can be used for porcelain to metal fabrication of single units and all bridge work including single and three or four crowns.
Product codes
EJT
Device Description
Not Found
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Not Found
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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 is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized image of a human figure with three heads or faces in profile, suggesting a sense of community or interconnectedness. The figure is positioned to the right of a circular border containing the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" in capital letters.
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 : K993136 Trade Name: Jel Bios 10 (Code Name RD-1801) Regulatory Class: II Product Code: EJT Dated: September 13, 1999 Received: September 20, 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 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 regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 895. ਬੈ 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 regulation 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 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 ene 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 the text "K993136" in a bold, sans-serif font. Below the numbers, the words "Page" and "of" are printed in a smaller font size. There are blank lines after the words "Page" and "of", presumably for writing in page numbers.
unknown. K993136 510(k) Number (if known):
Jel Bios 10 ( Code Name RD-1801 ) Device Name:
Indications For Use:
High Gold and Platinum containing ceramic alloy for porcelain to metal restorations. It is Palladium, Silver and copper free dental alloy with less than 2.0 % base metal. Jel bios 10 is a rich gold color hard gold base alloy with high yield strength and thermal stability. It is compatible with a wide range of porcelain available in the market. It can be used for porcelain to metal fabrication of single units and all bridge work including single and three or four crowns.
Jri Dis Dong A
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
yes Prescription Use (Per 21 CFR 801.109)
OR
Over-The-Counter Use No.
(Optional Format 1-2-96)
Division of Dental, Infectio and General Hospital I 510(k) Number