(37 days)
893385
Not Found
No
The summary describes a dental casting alloy and its physical properties, with no mention of software, algorithms, or any technology related to AI or ML.
No.
The device is a casting alloy used for dental restorations like inlays, onlays, and crowns, which are structural components and not directly involved in treating or alleviating a disease or medical condition.
No
This device is described as a casting alloy for dental restorations (inlays, onlays, crowns, bridges, removable partials), which are used to repair or replace missing tooth structure. It does not perform any diagnostic function.
No
The device description clearly states it is a "yellow casting alloy" and a "platinum-free crown and bridge 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 is for dental restorations (inlays, onlays, crowns, bridges, removable partials). This is a structural material used in the body, not a test performed on a sample taken from the body to diagnose a condition.
- Device Description: The description confirms it's a casting alloy for dental applications.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples, detecting analytes, or providing diagnostic information.
IVDs are devices used to examine specimens derived from the human body (like blood, urine, tissue) to provide information for the diagnosis, monitoring, or treatment of diseases or conditions. This device clearly falls outside of that definition.
N/A
Intended Use / Indications for Use
This is a yellow casting alloy for inlay / onlays, crowns, short span bridges, long span bridges, removable partials.
Product codes
EJT
Device Description
LUCIUS 76 is a platinum-free crown and bridge alloy. This device is dependable 76% gold alloy with a high gold appearance. LUCIUS 76 is an excellent for inlays, three-quarter crowns, long and short-span bridges.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
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 composition and physical/mechanical properties were conducted against the predicate device.
Composition (Weight %):
LUCIUS 76: Au (76.0%), Pt (1.0%), Pd (2.0%), Ag (11.3%), Cu (9.99%), Zn (0.68%)
Physical and Mechanical Properties:
LUCIUS 76: Melting Point Range (1,746-1,814 °F), Hardness (Vickers - 148), Yield Strength (MPa - 270), Elongation (% - 48.0)
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
893385
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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
10223196
510(K) SUMMARY
Submitter of 510(k): SB LUCIUS, INC. 9778 Katella Ave. Ste, 205, Anaheim, CA 92804 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: | LUCIUS 76 |
| Dental casting alloy | |
| Gold based alloys and precious metal alloys for | |
| clinical use | |
| Product code: | EJT |
| Classification: | Class II |
Legally marketed device: Argen's ARGENCO 77** 510(k) number: 893385
SUMMARY OF THE TECHNOLOGICAL CHARACTERISTICS
Test methods applied: as in ANSI/ADA 5 and ISO 9693
Comparison of composition:
| COMPOSITION (WEIGHT,%) | ||||||
|---|---|---|---|---|---|---|
| Device Name | Au (%) | Pt (%) | Pd (%) | Ag (%) | CU(%) | ZN(%) |
| Argenco 77** | 76.0 | 1.0 | - | 13.0 | 8.45 |