(81 days)
No
The summary describes a dental alloy material and its intended uses, with no mention of software, algorithms, or any technology related to AI or ML.
No.
The device is described as an "inlay, onlay, crown and bridge alloy" and is "intended for manufacturing" these dental prosthetics, which are restorative materials, not therapeutic devices.
No
The device is described as an "inlay, onlay, crown and bridge alloy" intended for manufacturing dental prosthetics, which is a restorative, not diagnostic, function.
No
The device description clearly states that AIGIS-XO is an "inlay, onlay, crown and bridge alloy," which 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 clearly states that AIGIS-XO is for manufacturing dental restorations like inlays, onlays, crowns, and bridges. These are devices used in the mouth for structural purposes, not for testing samples outside the body to diagnose or monitor a medical condition.
- Device Description: The description confirms it's a dental alloy used for creating these restorations.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), detecting analytes, or providing diagnostic information.
IVDs are devices used to perform tests on samples taken from the human body to provide information about a person's health. AIGIS-XO is a material used to create a physical structure within the body.
N/A
Intended Use / Indications for Use
AIGIS-XO is intended for manufacturing
- Inlay / Onlays -
- Crowns -
- Short span bridges "
- Long span bridges -
- Removable partials -
Product codes
EJT
Device Description
AIGIS-XO is a dental casting alloy, specifically gold based alloys and precious metal alloys for clinical use. It is described as an inlay, onlay, crown and bridge alloy, dependable 82% gold alloy with a high gold appearance.
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
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies
Test methods applied: as in ANSI/ADA 5 and ISO 9693. Comparison of composition and physical/mechanical properties were performed between AIGIS-XO and BIOCCLUS 4. The conclusion was that AIGIS-XO is substantially equivalent to BIOCCLUS 4 and the minor differences between them do not affect safety or effectiveness.
Key Metrics
Not Found
Predicate Device(s)
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
024145
MAR 0 7 2003
510(K) SUMMARY
SB LUCIUS, INC. Submitter of 510(k): 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: | Dec 15, 2002 |
| Trade name: | |
| Common: | |
| Classification name: | AIGIS-XO |
| Dental casting alloy | |
| Gold based alloys and precious metal alloys for | |
| clinical use | |
| Product code: | EJT |
| Classification: | Class II |
Legally marketed device: BIOCCLUS 4 510(k) number: K960104
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 | IR/In |
| BIOCCLUS 4 | 85.8 | 11.0 | - | - | - | 0.05 |