JELBOND NP by JELENKO CO. | FDA 510(k) Summary

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.

Device Description

AI/ML Overview

The provided document is a 510(k) premarket notification letter from the FDA for a dental alloy named Jelbond NP. This type of document declares substantial equivalence to a predicate device and does not typically contain detailed information about specific acceptance criteria or comprehensive study results as would be found in a full clinical or performance study report.

Therefore, the following information cannot be extracted from the given text:

A table of acceptance criteria and the reported device performance: This document does not detail specific performance metrics or acceptance criteria for the device beyond its classification as a predominantly base alloy.
Sample size used for the test set and the data provenance: No information about a test set or its provenance is available.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable, as detailed ground truth establishment for a specific test set is not described.
Adjudication method for the test set: Not applicable.
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: This is a material alloy, not an AI diagnostic device, so an MRMC study is not relevant and not discussed.
If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: Not applicable, as this is a material alloy.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not applicable to a material alloy's 510(k) submission in this format.
The sample size for the training set: Not applicable, as this is not an AI/algorithm-based device requiring a training set.
How the ground truth for the training set was established: Not applicable.

Summary of available information from the document:

Device Name: Jelbond NP
Regulatory Class: II
Product Code: EJH
Indications for Use: Jelbond NP is a predominantly base alloy designed for porcelain application and compatible with most regular porcelains in the market. It is a Nickel-Chrome alloy for ceramic and acrylic veneering for crown and bridgework, and is Beryllium, Boron, and Aluminum-free. Its thermal coefficient of expansion corresponds to standard types of dental porcelains.
Predicate Device: The letter states the device is "substantially equivalent... to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976." This implies that the performance of Jelbond NP is considered comparable to established predicate devices, rather than being proven through new, extensive clinical studies detailed in this specific document.
Reviewing Office: Division of Dental, Infection Control, and General Hospital Devices, Office of Device Evaluation, Center for Devices and Radiological Health.

This document serves as a regulatory clearance based on substantial equivalence, not a detailed performance study report.

Summary

{0}------------------------------------------------

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

{2}------------------------------------------------

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
------------------	-----	----	----------------------	----

Regulation Number and Section

§ 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.