(34 days)
No
The document describes a dental alloy with a specific chemical composition and intended uses, with no mention of software, algorithms, or any technology related to AI or ML.
No
The device is described as a high noble, yellow alloy for dental restorations like inlays, onlays, and crowns, which are used to restore the structure of teeth, not for therapeutic purposes.
No
Explanation: The device is described as a gold alloy for dental restorations (inlays, onlays, crowns, bridges, etc.), which are treatments, not diagnostic procedures.
No
The device description clearly states it is a "High Noble, Micro-fine, Yellow, Gold based alloy" with a specific chemical composition, indicating it 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 intended use clearly states that Gold Core 55 is a dental alloy used for creating dental restorations like inlays, onlays, crowns, bridges, etc. These are devices used in the mouth for structural purposes, not for testing samples in vitro (outside the body) to diagnose or monitor a medical condition.
- Device Description: The description details the chemical composition of a dental alloy. This is consistent with a material used for fabricating dental prosthetics, not a diagnostic reagent or instrument.
- 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 specific analytes (proteins, genes, pathogens, etc.)
- Providing diagnostic information
- Being used in a laboratory setting
In summary, Gold Core 55 is a dental material used for fabricating restorations, which falls under the category of medical devices, but not In Vitro Diagnostic devices.
N/A
Intended Use / Indications for Use
Gold Core 55 is a Type IV, high noble, yellow alloy to be used for inlays, onlays, single crown briges, implant superstructures and substrate for low wear products and other medium expansion lower fusing porcelains and indirect restorative composites. Particularly, OPC Low Wear, K982377, Jeneric/Pentron, which is a low temperature ceramic.
Product codes
EJT
Device Description
Gold Core 55 is a High Noble, Micro-fine, Yellow, Gold based alloy to be used for inlays, onlays, single crowns, bruges, imposites, and substrate for medium expansion lower fusing porcelains. Particularly to be used with OPC Low Wear, porcelains me menter resear porcelain. The chemical composition of Gold Core 55 is as follows: Au - 55%, Ag - 29%, Pd - 10%, Balance Amounts of: In, Sn, Zn, Ir.
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
Not Found
Key Metrics
Not Found
Predicate Device(s)
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.
0
OCT 26 1999
510(K)SUMMARY K993173
Jeneric/Pentron, Inc. Submitted by: 53 North Plains Industrial Road Wallingford, Connecticut 06492
Annmarie Tenero Contact Person: (203) 265-7397 X 619
October 20, 1999 Revised Summary:
Gold Core 55 Device Name:
Gold Core 55 is a High Noble, Micro-fine, Yellow, Gold based alloy to be used for inlays, onlays, Cord Corc 35 is a Fright Noberstructures, substrate for medium expansion lower fusing single crowns, brugos, imposites. Particularly to be used with OPC Low Wear, porcelains me menter resear porcelain. We believe that Gold Core 55 is substantially equivalent, to KB58-KF, K922958, Jeneric/Pentron, Inc., which is currently in commercial distribution in the U.S. A. The chemical composition of Gold Core 55 is as follows:
Au - 55% Ag - 29% Pd - 10% Balance Amounts of: In, Sn, Zn, Ir
Jeneric/Pentron, Inc. 510K Submission - Gold Core 55
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Image /page/1/Picture/1 description: The image shows the seal of the Department of Health & Human Services - USA. The seal is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the seal is a stylized image of an eagle with its wings spread.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
OCT 26 1999
Ms. Annmarie Tenero Jeneric®/Pentron® Incorporated 53 North Plains Industrial Road P.O. Box 724 Wallingford, CT 06492-0724
- K993173 Re : Gold Core 55 Trade Name: Requlatory Class: II Product Code: EJT September 17, 1999 Dated: Received: September 22, 1999
Dear Ms. Tenero:
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) requlation (21 CFR Part 820) and that, through periodic GMP inspections, the Food and Drug Administration (FDA) will Failure to comply with the GMP verify such assumptions. 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 - Ms. Tenero
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 the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other qeneral 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.fdangov/cdrh/dsmamain.html" a
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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Page _l of l
510(k) NUMBER (IF KNOWN): K993173
DEVICE NAME: GOLD CORE 55
INDICATIONS FOR USE:Gold Core 55 is a Type IV, high noble, yellow alloy to be used for inlays, onlays, single crown briges, implant superstructures and substrate for low wear products and other medium expansion lower fusing porcelains and indirect restorative composites. Particularly, OPC Low Wear, K982377, Jeneric/Pentron, which is a low temperature ceramic.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED.)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use (Per 21 CFR 801.109)
OR
Over-The-Counter-Use (Optional Format 1-2-
Susan Yunn
(Division Sign-Off) Division of Dental, Infection Control, and General Hospital D 510(k) Number .