(56 days)
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Not Found
No
The summary describes a dental alloy and contains no mention of AI, ML, image processing, or any other technology typically associated with AI/ML in medical devices.
No
The device is described as a high noble alloy for dental crowns and bridges, which is a material used in prosthetic dentistry rather than a therapeutic device designed to treat a disease or condition.
No
The document describes "Maintbonc. A" as a high noble alloy for dental applications (crowns and bridges, porcelain application). It is a material used for restoration, not a device that diagnoses a condition or disease.
No
The provided text describes a dental alloy, which is a physical material used in dental restorations. There is no mention of software, digital processing, or any other characteristics of a software-only medical device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly describes a dental alloy used for creating dental restorations (crowns and bridges). This is a material used in the mouth for structural purposes.
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body (like blood, urine, tissue) to detect diseases, conditions, or infections.
The description of Mainbond A fits the definition of a dental material, not an IVD.
N/A
Intended Use / Indications for Use
Maintbonc. A is a high noble alloy under Identalloy and ADA classification system for Dental alloy. It is designed for porcelain, application and compatible with low fusing porcelains in the market. Mainbond A is a rich yellow color, palladium free alloy and it provides quality restoration. It can also be used as Type-IV crown and bridge alloy. It polishes to a high luster and can be used for Single, 3 to 4 crowns.
Product codes
EJT
Device Description
Mainbond A is a high noble alloy under Identalloy and ADA classification system for Dental alloy. It is designed for porcelain, application and compatible with low fusing porcelains in the market. Mainbond A is a rich yellow color, palladium free alloy and it provides quality restoration. It can also be used as Type-IV crown and bridge alloy. It polishes to a high luster.
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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§ 872.3060 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 is a black and white logo for the Department of Health & Human Services - USA. The logo consists of a circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" written around it. Inside the circle is an abstract symbol that resembles an eagle or a bird in flight, composed of three curved lines.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JAN 1 3 1999
Mr. Tridib Dasqupta Director R & D and Q.C J.F. Jelenko & Company, Incorporated 99 Business Park Drive Armonk, New York 10504
K984140 Re: Trade Name: Mainbond A Requlatory Class: II Product Code: EJT November 16, 1998 Dated: Received: November 18, 1998
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 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 reqistration, listing of devices, good manufacturing practice, labeling, and prohibitions aqainst 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. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS 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 obligation you might have under sections 531
1
Page 2 - Mr. Dasgupta
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 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 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" (21CFR 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/dsma/dsmamain.html".
Sincerely yours
Timothy A. Ulatowski
Directbr Division of Dental, Infection Control, and General Hospital Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
JELENKO
J. F. JELENKO & CO.
DENTAL HEALTH PRODUCTS
| 99 BUSINESS PARK DRIVE. ARMONK, NEW YORK U.S.A. 10504 | (914) 273-8600 |
|---|---|
| FAX: (914) 273-9379 |
| Page | / of / |
|---|---|
| ------ | -------- |
| 510(k) Number (if known): | K984140 |
|---|---|
| Device Name: | Mainbond A |
Indications For Use:
| 55 × 100 | |||
|---|---|---|---|
| Production 245 | Maintbonc. A is a high noble alloy under Identalloy and ADA | ||
| classification system for Dental alloy. It is designed for porcelain, | |||
| application and compatible with low fusing porcelains in the | |||
| market. Mainbond A is a rich yellow color, palladium free alloy | |||
| and it provides quality restoration. It can also be used as Type-IV | |||
| used for Single, 3 to 4 crowns. | crown and bridge alloy. It polishes to a high luster and can be | ||
| (PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED) | |||
| currence of CDRH, Office of Device Evaluation (ODE) | |||
| (Division Sign-Off) | |||
| Division of Dental, Infection Control, | |||
| and General Hospital Devices | |||
| Kayılıyı | |||
| 510(k) Number . | |||
| Prescription Use | 68 | OR | No . |
| Over-The-Counter Use |
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