(37 days)
Not Found
No
The document describes a dental alloy and its physical properties, with no mention of AI or ML.
No
The device is described as a ceramic alloy used for dental prosthetics such as crowns and bridges, which are restorative rather than therapeutic in nature. It replaces existing structures but does not prevent, treat, or cure a disease or condition.
No
Explanation: The device is a dental alloy used for fabricating restorations such as crowns and bridges. Its intended use and device description focus on its material properties for restorative purposes, not for diagnosing medical conditions.
No
The device description clearly states it is a "yellow ceramic alloy" and a "High Noble, Micro-fine, Yellow, Gold based alloy," indicating it 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/Indications for Use: The intended use clearly describes a material for creating dental prosthetics (crowns, bridges, etc.) for use within the body. IVDs are used to examine specimens from the body (like blood, urine, tissue) to diagnose or monitor conditions.
- Device Description: The description details a ceramic alloy used for dental restorations, not for analyzing biological samples.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples, diagnostic purposes, or any of the typical components or processes associated with IVDs.
The device is a dental material intended for direct use in patients for restorative purposes.
N/A
Intended Use / Indications for Use
This is a yellow ceramic alloy for single units, implants prosthetics, single & 3/4 crowns, and short span bridges.
Product codes
EJT
Device Description
CERANUM 90 is a High Noble, Micro-fine, Yellow, Gold based alloy to be used for inlays, onlays, single crowns, bridge, implant superstructures and substrate for medium expansion with lower fusing porcelains and indirect restorative composites. CERANUM 90 is a high gold ceramic alloy, which heightens the porcelain esthetics of the restoration and provides strength. durability and color of gold.
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)
Comparison of physical and mechanical properties were tested as in ANSI/ADA 5 and ISO 9693, and compared against the predicate device.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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Predicate Device(s)
Reference Device(s)
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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.
0
1 2002 NOV
510(K) SUMMARY
Submitter of 510(k): SB LUCIUS, INC. Ste.205, Anaheim, CA 92804 9778 Katella Ave. Phone: (714) 530-2814, Fax : (714) 530-3448,
| Contact person: | Dae-Kyu Chang |
|---|---|
| Phone: | (714) 530-2814 |
| Fax: | (714) 530-3448 |
| E-mail: | Gatorkr@yahoo.co.kr |
| Date of Summary: | Sept. 16, 2002 |
| Trade name: | CERANUM 90 |
| Common: | Dental casting alloy |
| Classification name: | Gold based alloys and precious metal alloys for |
| clinical use | |
| Product code: | EJT |
| Classification: | Class II |
Legally marketed device: Jel Bios 90 510(k) number: K001196
SUMMARY OF THE TECHNOLOGICAL CHARACTERISTICS
Test methods applied: as in ANSI/ADA 5 and ISO 9693
Comparison_of composition:
| Device Name | Au | Pt | Pd | Ag | CU | Sn | FE | Zn |
|---|---|---|---|---|---|---|---|---|
| Jel Bios 90 | 90.00 | 7.40 | - | 1.0 | - | - |