(36 days)
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No
The 510(k) summary describes a dental alloy material and does not mention any software, image processing, or AI/ML terms.
No.
The device is a material for constructing dental restorations, not a device used to treat a disease or condition.
No
The device is described as an alloy for the construction of dental restorations (crown and bridge), not for diagnosing medical conditions.
No
The device description explicitly states it is a metal alloy for dental restorations, which is a physical material, not software.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body (like blood, urine, tissue) to provide information about a person's health.
- Device Description and Intended Use: The description clearly states that this device is a dental alloy used for constructing dental restorations (crowns and bridges). It is a material used in the mouth, not a device used to test samples from the body.
Therefore, based on the provided information, this device falls under the category of a dental material or device, not an IVD.
N/A
Intended Use / Indications for Use
This device is a non precious, nickel-chromium-molybdenum-beryllium based alloy for use in the construction of cast ceramic bonded crown and bridge restorations.
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 (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)
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Reference Device(s)
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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 circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract symbol resembling an eagle or bird in flight, composed of three curved lines.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAR - 3 2004
Mr. Vincent M. Benetti Vice President, General Manager Aalba Dent, Incorporated 400 Watt Drive Cordelia, California 94534
Re: K040179
Trade/Device Name: Continum™ Trade/Dion Number: 21 CFR 872.3710 Regulation Name: Base Metal Alloy Regulatory Class: II Product Code: EJH Dated: January 23, 2004 Received: January 27, 2004
Dear Mr. Benetti:
We have reviewed your Section 510(k) premarket notification of intent to market the device to We have reviewed your Section 500(k) premarket in this to ntalent (for the indications for referenced above and have determined the devices marketed in therstate commence
use stated in the enclosure) to legally marketed predicate devices marketed in use stated in the enclosure) to legally marketed previews manded mass of to devices that
prior to May 28, 1976, the enactment date of the Federal Food, Drug, I prior to May 28, 1976, the enactment date of the Medical Device I handali, bug, and Cosmetic
have been reclassified in accordance with the provisions of the Federal Food. Dru have been reclassified in accordance with the provisions of me redication (PMA). You may,
Act (Act) that do not require approval of a premarket approval application of the A Act (Act) that do not require approval of a premiere approval appovisions of the eeneral
therefore, market the device, subject to the general controls provisions of the estab the ( market the device, subject to the general controls or alle from the research in the research and advices, good
controls provisions of the Act include requirements for a controls provisions of the Act include requirements for animals region.
manufacturing practice, labeling, and prohibitions against misbranding and adulteration.
The manufactu
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it If your device is classified (see above) into either class in (special concoln) on one of (