(43 days)
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No
The summary describes a dental alloy material and does not mention any computational or algorithmic components, let alone AI/ML.
No.
The device is a gold/platinum alloy used for dental restorations like longspans and bridges, which is a structural material, not a device intended to treat or prevent a disease or condition.
No
The device is described as a gold/platinum porcelain-to-metal alloy used for dental restorations like longspans and bridges. Its intended use focuses on the material's properties for creating restorative devices, not on diagnosing medical conditions.
No
The device description clearly states it is a gold/platinum porcelain-to-metal 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 dental alloy for creating longspans and bridges, which are restorations placed in the mouth. This is a medical device used for treatment or restoration within the body, not for testing samples in vitro (outside the body).
- Device Description: The description confirms it's a dental alloy with specific material properties.
- Lack of IVD Characteristics: There is no mention of analyzing samples (blood, urine, tissue, etc.), detecting diseases, or providing diagnostic information based on in vitro testing.
Therefore, this device falls under the category of a dental restorative material, which is a type of medical device, not an IVD.
N/A
Intended Use / Indications for Use
It is a gold / platinum porcelain-to-metal alloy with high strength and hardness with superfine grain structure. It is suitable for longspans and bridges. It is a high noble alloy and the high goldcontent makes it compatible with most porcelains in the market.Jelbond-PdF blend well with tissue and enhances the esthetic qualities of the finished restoration.
Product codes
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
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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.
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Image /page/0/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with three stripes representing the three branches of government. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the eagle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAY 2 0 1997
Mr. Tridib Dasgupta Director R&D and Q.C J.F. Jelenko and Company 99 Business Park Drive Armonk, New York 10504 USA
Re : K971574 Trade Name: Jelbond-PdF 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, 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 Requlations, Title 21, Parts 800 to 895. ਕੇ 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 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.
1
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.gov/cdrh/dsmamain.html".
Sincerely yours,
Timothy A. Ulatowski
av A. Ulatowsk Director Division of Dental, Infection Control, and General Hospital Devices Office of Device Evaluation Center for Devices and Radioloqical Health
Enclosure
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99 BUSINESS PARK DRIVE, ARMONK, NEW YORK 10504 USA
| 12- 9-96; | 9:40; | 301 480 3002 => JELENKO_; #3 | (800) 431-1785 |
|---|---|---|---|
| 2/09/96 MON 09:45 FAX 301 480 3002 | FDA/ODE/DDIGD | 003 |
Page 1 of 1
| 510(k) Number (if known): | not available |
|---|---|
| Device Name: | Jelbond-PdF |
Indications For Use:
It is a gold / platinum porcelain-to-metal alloy with high strength and hardness with superfine grain structure. It is suitable for longspans and bridges. It is a high noble alloy and the high goldcontent makes it compatible with most porcelains in the market.Jelbond-PdF blend well with tissue and enhances the esthetic qualities of the finished restoration.
Rich Daggett...
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Susar Kunnes
(Divison Sign-Off)
Division of Dental, Infection Control,
and General Hospital Devices 510(k) Number
Prescription Use yES (Per 21 CFR 801.109) OR
Over-The-Counter Use No
(Optional Format 1-2-96)