(34 days)
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.
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
The provided text is a 510(k) summary for a dental alloy named "Gold Core 75". It states that the device is substantially equivalent to a previously marketed device, BIO74-PF Crown and Bridge Alloy (K943487). This type of submission (510(k)) focuses on demonstrating substantial equivalence to a predicate device rather than providing extensive clinical study data with specific performance metrics and ground truth establishment as would be seen for novel or high-risk devices.
Therefore, the requested information regarding acceptance criteria, device performance, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, and ground truth establishment for a study proving device performance is not present in this document. The document primarily focuses on chemical composition and intended use to establish substantial equivalence.
Here's how the provided information relates to your request:
1. A table of acceptance criteria and the reported device performance
- Acceptance Criteria: Not explicitly stated as pass/fail criteria for a study. The acceptance criterion for the 510(k) submission itself is "substantial equivalence" to a predicate device (BIO74-PF Crown and Bridge Alloy, K943487).
- Reported Device Performance: The document lists the chemical composition of Gold Core 75: Au - 75%, Ag - 17%, Pt - 4.5%, Rh - 0.5%, Balance (Zn, Ta, In, Ir). It also implicitly states its performance by declaring its intended uses (inlays, onlays, single crowns, bridges, implant superstructures, substrate for medium expansion lower fusing porcelains and indirect restorative composites). The basis of "performance" in this context is its chemical composition and intended use closely matching the predicate device.
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Not applicable/Not provided. The 510(k) does not describe a clinical study with a test set of data. Substantial equivalence is often based on material characterization and comparison to predicate device specifications.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
- Not applicable/Not provided. No test set requiring expert ground truth is described.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable/Not provided. No test set requiring adjudication is described.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
- Not applicable/Not provided. This is a material (dental alloy), not an AI-powered diagnostic device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable/Not provided. This is a material, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- Not applicable/Not provided. No ground truth in the context of a clinical study is described. The "truth" for this submission is the established performance and characteristics of the predicate device.
8. The sample size for the training set
- Not applicable/Not provided. This is a material, not a machine learning model.
9. How the ground truth for the training set was established
- Not applicable/Not provided. This is a material, not a machine learning model.
{0}------------------------------------------------
OCT 26 1999
20.0 510(K)SUMMARY K993175
| Submitted by: | Jeneric/Pentron, Inc.53 North Plains Industrial RoadWallingford, 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 RoadWallingford, 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 _
§ 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.