(58 days)
Not Found
Not Found
No
The summary describes a dental alloy with material properties, not a software or imaging device that would typically incorporate AI/ML.
No
The device is described as an alloy for restorative dental work (inlays, crowns, bridgework), which is a prosthetic or restorative material, not a therapeutic device designed to treat a disease or condition.
No
Explanation: The device is described as an "extra hard alloy for Hard Inlays, Crowns, Fixed Bridgework" and for "restorative works." This indicates it is a material used for dental restoration, not for diagnosing medical conditions.
No
The device description clearly states it is a "Type-IV extra hard 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 describes a material for creating dental restorations (inlays, crowns, bridges). This is a medical device used in vivo (within the body) for structural purposes.
- Device Description: The description confirms it's a dental alloy.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens in vitro (outside the body) to provide information about a physiological state, health, or disease. IVDs typically involve analyzing samples like blood, urine, tissue, etc.
Therefore, this device falls under the category of a dental restorative material, which is a type of medical device, but not an IVD.
N/A
Intended Use / Indications for Use
It is palladium free, rich gold colored, Type-IV extra hard alloy for Hard Inlays, Crowns, Fixed Bridgework. This High noble alloy offers strength, resilency and hardness for hard inlays and longspan bridges. It resists tarnish and discoloration and can be quenched (Soft ) and heat-treated ( Hardened ).It can be used for restorative works.
Product codes (comma separated list FDA assigned to the subject device)
EJT
Device Description
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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.
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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.
0
Image /page/0/Picture/1 description: The image shows the seal of the U.S. Department of Health & Human Services. The seal is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of an eagle with its wings spread, which is a common symbol of the United States. The eagle is depicted in black and white.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUN - 4 1997
Mr. Tridib Dasgupta Director R&D and Q.C. J.F. Jelenko & Company, Incorporated 99 Business Park Drive Armonk, New York 10504 USA
RË : K971575 Benchmark-IV Trade Name: Requlatory Class: II Product Code: EJT Dated: April 3, 1997 Received: April 7, 1997
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 regulations affecting your device can be found in the Code of Federal Requlations, Title 21, Parts 800 to 895. ਸੀ 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 regulatory action. In addition, FDA may publish further announcements concerning your device in Please note: this response to your the Federal Reqister.
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Page 2 - Mr. Dasgupta
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premarket notification submission does not affect any 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 requlations.
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.gqv/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
2
DENTAL HEALTH PRODUCTS
ISO 900 REGISTERED
| BUSINESS PARK DRIVE, ARMONK, NEW YORK 10504 USA | (800) 431-1785 |
|---|---|
| ------------------------------------------------- | ---------------- |
| 12- 9-96; 9:40; 301 480 3002 => JELENKO_; #3 FDA/ODE/DDIGD 2/09/96 MON 09:45 FAX 301 480 3002 | 003 |
|---|---|
| ----------------------------------------------------------------------------------------------- | ----- |
Page 1 of 1
| 510(k) Number (if known): | not available. |
|---|---|
| Device Name: | Benchmark- IV |
Indications For Use:
ﺘﺎﺯﺍﺕ ﺍﻟﻤﺴﺎﻋﺪﺓ ﺍﻟﻤﺴﺎﺣﺔ ﺍﻟﻤﻮﺍﻗﻌﺔ ﺍﻟﻤﻮﺍﻗﻌﺔ ﺍﻟﻤﻮﺍﻗﻌﺔ ﺍﻟﻤﻮﺿﻮﻋﺎﺕ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤ
ﺘﻘﺪﻡ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺪﻳﻨﺔ ﻭﺍﻟﻘﺎﺑﻠﺔ ﺍﻟﻤﺴﺎﻋﺪ ﺍﻟﻤﻘﺎﻃﻌﺎﺕ ﺍﻟﻤﺴﺎﻋﺪﺓ ﺍﻟﻤﺴﺎﻋﺪﺓ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤ
It is palladium free, rich gold colored, Type-IV extra hard alloy for Hard Inlays, Crowns, Fixed Bridgework. This High noble alloy offers strength, resilency and hardness for hard inlays and longspan bridges. It resists tarnish and discoloration and can be quenched (Soft ) and heat-treated ( Hardened ).It can be used for restorative works.
Ri. H. Denger R..
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Dushemes
(Division Sign-Off) Division of Dental, Infection Control, and General Hospital Devices 510(k) Number
VES Prescription Use (Per 21 CFR 801.109)
OR
Over-The-Counter Use NO