(41 days)
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No
The summary describes a dental alloy and its intended use, with no mention of software, algorithms, or any technology related to AI or ML.
No
This device is a dental alloy used for manufacturing crowns, bridges, and implant superstructures, which are restorative devices, not therapeutic.
No
The device is described as a high-gold ceramic alloy used for manufacturing dental restorations like crowns, bridges, and implant superstructures. It is a material used for fabrication, not a device that performs diagnostic functions by detecting or identifying diseases or conditions.
No
The device description clearly states it is 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: The intended use is for manufacturing dental restorations (crowns, bridges, implant superstructures). This is a direct application within the body, not for testing samples taken from the body.
- Device Description: The description details a dental alloy used for creating physical dental prosthetics. It doesn't mention any function related to analyzing biological samples.
- Lack of IVD Characteristics: The document does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological samples (blood, urine, tissue, etc.)
- Providing diagnostic information
- Using reagents or assays
Therefore, CERANUM 82 is a dental material used for manufacturing restorations, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
CERANUM 82 is intended for manufacturing:
- Single Crown -
- Bridges -
- Implant superstructures
Product codes
EJT
Device Description
CERANUM 82 is a High Noble, Micro-fine, Yellow, Gold based alloy to be used for single crowns, bridge, implant superstructures and substrate for medium expansion with lower fusing porcelains and indirect restorative composites. CERANUM 82 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
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Key Metrics
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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
5 2002 NOV
510(K) SUMMARY
SB LUCIUS, INC. Submitter of 510(k): 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: | |
| Common: | |
| Classification name: | CERANUM 82 |
| Dental casting alloy | |
| Gold based alloys and precious metal alloys for | |
| clinical use | |
| Product code: | EJT |
| Classification: | Class II |
Legally marketed device: Metalor's V-Supragold 510(k) number: K993508
SUMMARY OF THE TECHNOLOGICAL CHARACTERISTICS
Test methods applied: as in ANSI/ADA 5 and ISO 9693
Comparison of composition:
| Device Name | Au (%) | Pt (%) | Pd (%) | In (%) | Ir | Ta |
|---|---|---|---|---|---|---|
| V-Supragold | 83.00 | 8.8 | 5.20 | 2.8 |