(34 days)
No
The 510(k) summary describes a dental alloy with a specific chemical composition and intended uses for dental restorations. There is no mention of software, algorithms, or any technology related to AI or ML.
No
Gold Core 75 is a dental alloy used for inlays, onlays, crowns, bridges, and implant superstructures. These are considered restorative materials, not therapeutic devices that treat a disease or condition. Its purpose is to replace or restore tooth structure.
No
The device, Gold Core 75, is described as a restorative dental alloy (for inlays, onlays, crowns, bridges, etc.) and not for diagnosing medical conditions.
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 75 is a dental alloy used for creating dental restorations like inlays, onlays, crowns, bridges, and implant superstructures. These are devices used in the mouth for structural purposes.
- Device Description: The description details the material composition of the alloy, which is consistent with 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 (like blood, urine, tissue, etc.) to provide information for diagnosis, monitoring, or treatment.
IVD devices are used outside the body to analyze biological samples. This device is used inside the body as a structural component.
N/A
Intended Use / Indications for Use
Gold Core 75 is a, high noble, yellow alloy, to be used for inlays, onlays, single crown bridges, implant superstructures and substrate for low wear products and other medium expansion lower fusing porcelains and indicret restorative composites. Particularly, OPC Low Wear, K982377, Jeneric/Pentron, which is a low temperature ceramic.
Product codes
EJT
Device Description
Gold Core 75 is a High Noble, Micro-fine, Yellow, Gold based alloy to be used for inlays, onlays, single crowns, bridges, implant superstructures, substrate for medium expansion lower fusing porcelains and indirect restorative composites. Particularly to be used with OPC Low Wear, K982377, which is a low wear porcelain. The chemical composition of Gold Core 75 is as follows: Au - 75% Ag - 17% Pt-4.5% Rh - 0.5% Balance Amounts of: Zn, Ta, In, 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)
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
20.0 510(K)SUMMARY K993175
| Submitted by: | Jeneric/Pentron, Inc.
53 North Plains Industrial Road
Wallingford, Connecticut 06492 |
|------------------|--------------------------------------------------------------------------------------------|
| Contact Person: | Annmarie Tenero
(203) 265-7397 X 619 |
| Revised Summary: | October 20, 1999 |
| Device Name: | Gold Core 75 |
Gold Core 75 is a High Noble, Micro-fine, Yellow, Gold based alloy to be used for inlays, onlays, single crowns, bridges, implant superstructures, substrate for medium expansion lower fusing porcelains and indirect restorative composites. Particularly to be used with OPC Low Wear, K982377, which is a low wear porcelain. We believe that Gold Core 75, besides containing no copper, is substantially equivalent to BIO74-PF Crown and Bridge Alloy, K943487, Jeneric/Pentron, Inc., which is currently in commercial distribution in the U.S. A. The chemical composition of Gold Core 75 is as follows:
Au - 75% Ag - 17% Pt-4.5% Rh - 0.5% Balance Amounts of: Zn, Ta, In, Ir
Jeneric/Pentron, Inc. 510K Submission - Gold Core 75
1
Image /page/1/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized symbol consisting of three abstract human profiles facing to the right, stacked on top of each other. The profiles are connected by curved lines, creating a sense of unity and flow.
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
K993175 Re : Gold Core 75 Trade Name: Requlatory Class: II EJT Product Code: Dated: September 17, 1999 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 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. ਨਾ 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 requlatory 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
2
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 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 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.fda.gov/cdrh/dsmamain.html".
Sincerely yours,
Timothy A. Ulatowski
Timothy A. Ulatowski Director Division of Dental, Infection Control and General Hospital Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
3
0CT 26 1999
20.0 510(K)SUMMARY K993175
| Submitted by: | Jeneric/Pentron, Inc.
53 North Plains Industrial Road
Wallingford, Connecticut 06492 |
|------------------|--------------------------------------------------------------------------------------------|
| Contact Person: | Annmarie Tenero
(203) 265-7397 X 619 |
| Revised Summary: | October 20, 1999 |
| Device Name: | Gold Core 75 |
Gold Core 75 is a High Noble, Micro-fine, Yellow, Gold based alloy to be used for inlays, onlays, single crowns, bridges, implant superstructures, substrate for medium expansion lower fusing porcelains and indirect restorative composites. Particularly to be used with OPC Low Wear, K982377, which is a low wear porcelain. We believe that Gold Core 75, besides containing no copper, is substantially equivalent to BIO74-PF Crown and Bridge Alloy, K943487, Jeneric/Pentron, Inc., which is currently in commercial distribution in the U.S. A. The chemical composition of Gold Core 75 is as follows:
Au - 75% Ag - 17% Pt - 4.5% Rh - 0.5% Balance Amounts of: Zn, Ta, In, Ir
Jeneric/Pentron, Inc. 510K Submission - Gold Core 75
4
Image /page/4/Picture/1 description: The image shows the logo for the U.S. Department of Health & 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 that resembles three abstract human figures or birds in flight, arranged in a layered or overlapping manner.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
0CT 26 1999
Ms. Annmarie Tenero Jeneric®/Pentron® Incorporated 53 North Plains Industrial Road P.O. Box 724 06492-0724 Wallingford, CT
Re: K993175 Trade Name: Gold Core 75 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, qood 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 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 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
5
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 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 ene orders of compliand, "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
Timothy A. Ulatowski Director Division of Dental, Infection Control and General Hospital Devices Office of Device Evaluation Center for Devices and Radioloqical Health
Enclosure
6
Paqe of
K993175 510(k) NUMBER (IF KNOWN) :
GOLD CORE 75 DEVICE NAME:
INDICATIONS FOR USE:Gold Core 75 is a, high noble, yellow alloy, to be used for inlays, onlays, single crown bridges, implant superstructures and substrate for low wear products and other medium expansion lower fusing porcelains and indicret 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 1-2-5
Susan Dunn
(Division Sign-Off) Division of Dental, Infection Control, and General Hospital 51 "(k) Number _