(39 days)
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Not Found
No
The summary describes a dental alloy and does not mention any software, algorithms, or data processing that would indicate the use of AI/ML.
No
This device is a material (alloy) used for dental restorations (crowns and bridgework), not a device that directly performs therapy.
No
The device is described as a dental alloy for porcelain and acrylic veneering, with no indication of diagnostic capabilities or intended use for diagnosing conditions.
No
The device description clearly states it is a dental alloy, which is a physical material, not software.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that Jelbond NP is a dental alloy designed for porcelain application and veneering for crown and bridgework. This is a material used in the mouth for dental restorations.
- Device Description: The description reinforces its use as a dental alloy for crowns and bridges.
- 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. Jelbond NP is a material used inside the body as part of a dental restoration.
N/A
Intended Use / Indications for Use
Jelbond NP is a predominantly base alloy under ADA / ANSI and Identalloy classification system for dental alloy. It is designed for porcelain application and comaptible with most of the regular porcelains in the market. Jelbond NP is a Nickel-Chrome alloy for ceramic and acrylic veneering for crown and bridgework. It is Barylium, Boron and Aluminum free White color non-precious alloy. It's thermal coefficient of expansion corresponds to standard types of dental porcelains in the market.
Product codes
EJH
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
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Key Metrics
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Predicate Device(s)
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Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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§ 872.3710 Base metal alloy.
(a)
Identification. A base metal alloy is a device composed primarily of base metals, such as nickel, chromium, or cobalt, that is intended for use in fabrication of cast or porcelain-fused-to-metal crown and bridge restorations.(b)
Classification. Class II (special controls). The special control for this device is FDA's “Class II Special Controls Guidance Document: Dental Base Metal Alloys.” The device is 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/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized caduceus symbol, which is a staff with two snakes coiled around it, representing medicine and healing. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the symbol. The logo is black and white.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
DEC 2 9 1998
Mr. Tridib Dasgupta Director R & D and Q.C J.F. Jelenko & Company, Incorporated 99 Business Park Drive Armonk, New York 10504
K984164 Re : Jelbond NP Trade Name: Regulatory Class: II Product Code: EJH Dated: November 19, 1998 November 20, 1998 Received:
Dear Mr. Dasqupta:
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 legally marketed predicate 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 Requlations, Title 21, Parts 800 to 895. ਕ substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical General regulation (21 CFR Part 820) and that, Devices: through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory In addition, FDA may publish further announcements action. 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
1
Page 2 - Mr. Dasgupta
through 542 of the Act for devices under the Electronic curough Jr. On Control provisions, or other Federal laws or regulations.
This letter will allow you to begin marketing your device as first ited in your 510(k) premarket notification. The FDA described in four tial equivalence of your device to a legally marketed predicate device results in a classification for your marketed predious and the 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 Compriance at (502) wertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note ene office or completed, "Misbranding by reference to premarket notification" (21CFR 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/dsma/dsmamain.html".
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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Image /page/2/Picture/0 description: The image shows the logo for Jelenko Dental Health Products. The logo is in black and white and features the word "JELENKO" in large, bold letters. Below the company name, it says "DENTAL HEALTH PRODUCTS" and "ISO 9001 REGISTERED" in a smaller font.
99 BUSINESS PARK DRIVE. ARMONK. NEW YORK 10504 USA htr w.jelenko.com
(800) 431-1785 PHONE: (914) 273-8600
Page of
510(k) Number (if known): K984164
Device Name: Telbond NP
Indications For Use:
(Per 21 CFR 801.109)
Jelbond NP is a predominantly base alloy under ADA / ANSI and Identalloy classification system for dental alloy. It is designed for porcelain application and comaptible with most of the regular porcelains in the market. 彩票 六肖 Jelbond NP is a Nickel-Chrome alloy for ceramic and acrylic veneering for crown and bridgework. It is Barylium, Boron and Aluminum free White color non-precious alloy. It's thermal coefficient of expansion corresponds
to standard types of dental porcelains in the market. :
Por 1 Jan
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
| Susan Runser (Division Sign-Off) Division of Dental, Infection Control and General Hospital | |
|---|---|
| 510(k) Number | K984164 |
| Prescription Use | Yes | OR | Over-The-Counter Use | No |
|---|---|---|---|---|
| ------------------ | ----- | ---- | ---------------------- | ---- |