(84 days)
Not Found
No
The summary describes a dental alloy with physical and mechanical properties, not a software or system that would typically incorporate AI/ML. There are no mentions of AI, ML, image processing, or data sets for training/testing.
No
The device is described as an "inlay, onlay, crown and bridge alloy" intended for manufacturing dental restorations, which are considered prosthetic devices, not therapeutic.
No
The device description indicates AIGIS-SOFT is an alloy used for manufacturing dental prosthetics, not for diagnosing medical conditions.
No
The device description clearly states it 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 is for manufacturing dental restorations (inlays, onlays, crowns, bridges, removable partials). This is a manufacturing process for a medical device, not a diagnostic test performed on biological samples.
- Device Description: The device is described as a dental alloy, a material used to create these restorations.
- Lack of Diagnostic Elements: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), detecting diseases, or providing diagnostic information.
- Performance Studies: The performance studies focus on the physical and mechanical properties of the alloy, which are relevant to its use in dental restorations, not diagnostic accuracy.
IVD devices are specifically designed to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device does not fit that description.
N/A
Intended Use / Indications for Use
AIGIS-SOFT is intended for manufacturing
- Inlay / Onlays
- Crowns
- Short span bridges
- Long span bridges "
- Removable partials -
Product codes (comma separated list FDA assigned to the subject device)
EJT
Device Description
AIGIS-SOFT is an inlay, onlay, crown and bridge alloy. This device is dependable 83% gold alloy with a high gold appearance. AIGIS-SOFT is 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
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
Test methods applied: as in ANSI/ADA 5 and ISO 9693
Comparison of composition: Not Readable
Comparison of physical and mechanical properties:
| Alloy | Melting Point Range (°F) | Hardness (Vickers) | Yield Strength (MPa) | Elongation (%) | Density (g/cm3) |
|---|---|---|---|---|---|
| ARGENCO 83 | 1,730-1,760 | 80 | 103 | 35 | 16.6 |
| AIGIS-SOFT | 1,922-2,002 | 60 | 85 | 45 | 17.2 |
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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
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: Dec 15, 2002
| Trade name: | AIGIS-SOFT |
|---|---|
| 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: ARGENCO 83 510(k) number: K893384
SLMMARY OF THE TECHNOLOGICAL CHARACTERISTICS
Test methods applied: as in ANSI/ADA 5 and ISO 9693
Comparison of composition:
| COMPOSITION (WEIGH
| 10 | ||||||||
|---|---|---|---|---|---|---|---|---|
| evice Name | F | |||||||
| 1 | ||||||||
| A MIN CHANNEW AND THE LE AND START CONNECT CONNUMER CONNUM | ||||||||
| of an and any anyway | ||||||||
| T | ||||||||
| I | 3 | |||||||
| 1 | CONSULTION COLLECTION CONSULTER CONSULTER COUNCE CONSULTION CONSULTION AND CONSULTION CONSULTION AND CONSULTION CONSULTION CONSULTION CONSULTION CONSULTION CONSULTION CONSULT |
COMPOSITION (WEIGHT %)
Comparison of physical and mechanical properties:
| Alloy | Melting Point Range (°F) | Hardness (Vickers) | Yield Strength (MPa) | Elongation (%) | Density (g/cm3) |
|---|---|---|---|---|---|
| ARGENCO 83 | 1,730-1,760 | 80 | 103 | 35 | 16.6 |
| AIGIS-SOFT | 1,922-2,002 | 60 | 85 | 45 | 17.2 |
1
Ciscussion:
Since the composition of the legally marketed alloy and the new device is very similar, it may be assumed that the biological compatibility of the alloys is also very similar.
Conclusion:
The main elements and their concentration are almost identical. AIGIS-SOFT is an inlay, onlay, crown and bridge alloy. This device is dependable 83% gold alloy with a high gold appearance. AIGIS-SOFT is excellent for inlays, three-quarter crowns, long and short-span bridges. AIGIS-SOFT is substantially equivalent to ARGENCO 83 and the minor differences between them do not affect safety or effectiveness.
2
Image /page/2/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features the department's symbol, which is a stylized caduceus with three lines representing the human form. The symbol is placed to the right of the text, which is arranged in a circular pattern around the symbol. The text reads "DEPARTMENT FOR HEALTH & HUMAN SERVICES - USA".
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAR 1 0 2003
Mr. Dae-Kyu Chang President SB Lucius, Incorporated 9778 Katella Avenue, Suite 205 Anaheim, California 92804
Re: K024136 Trade/Device Name: AIGIS-SOFT Regulation Number: 872.3060 Regulation Name: Gold-Based Alloys and Precious Metal Alloys for Clinical Use Regulatory Class: II Product Code: EJT Dated: December 15, 2002 Received: December 16, 2002
Dear Mr. Chang:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition. FDA may publish further announcements concerning your device in the Federal Register.
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Page 2 - Mr. Chang
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at (301) 594-4613. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers. International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html
Sincerely vours.
Susan Quares
Susan Runner, DDS, MA Interim Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
SB LUCIUS, INC 9778 Katella Ave. Ste. 205, Anaheim, CA 92804
Phone: (714) 530-2814, Fax : (714) 530-3448,
INDICATIONS FOR USE
510(K) Number : K024136
Device Name(s) : AIGIS-SOFT
AIGIS-SOFT is intended for manufacturing
- Inlay / Onlays -
- Crowns -
- Short span bridges -
- Long span bridges "
- Removable partials -
(PLEASE DO NOT WRITE BELOW THIS LINE CONTINUE ON ANOTHER PAGE IF NEEDED)
CONCURRENCE OF CHRD,OFFICE OF DEVICE EVALUATION(OE.D)
==============================================================================================================================================================================
MR a/h for MSR
nesthesiology, General Hospital. 510(k) Number.