(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.
No.
The device is described as an alloy for manufacturing dental restorations (inlays, onlays, crowns, bridges), which are prosthetics rather than devices intended to treat or prevent a disease or condition.
No
The provided text explicitly states that AIGIS-PLUS is an "inlay, onlay, crown and bridge alloy" intended for "manufacturing" dental restorations, 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. The performance studies also focus on physical and mechanical properties.
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-PLUS is for manufacturing dental restorations like inlays, onlays, crowns, and bridges. These are devices used in the body to restore dental function and aesthetics.
- Device Description: The description confirms it's a gold alloy used for these dental applications.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens derived from the human body (like blood, urine, tissue, etc.) to provide information for diagnosis, monitoring, or treatment. The information provided focuses on the material properties and its use in creating dental prosthetics.
Therefore, AIGIS-PLUS is a dental material used in the manufacturing of medical devices (dental restorations), but it is not an in vitro diagnostic device itself.
N/A
Intended Use / Indications for Use
AIGIS-PLUS 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-PLUS is an inlay, onlay, crown and bridge alloy. This device is dependable 56% gold alloy with a high gold appearance. AIGIS-PLUS 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)
Comparison of physical and mechanical properties:
Alloy: ARGENCO 56; Melting Point Range (°F): 1,600-1,710; Hardness (Vickers): 186; Yield Strength (MPa): 372; Elongation (%): 38; Density (g/cm3): 13.6
Alloy: AIGIS-PLUS; Melting Point Range (°F): 1,690-1,742; Hardness (Vickers): 154; Yield Strength (MPa): 300; Elongation (%): 15; Density (g/cm3): 13.7
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
MAR 1 0 2003
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 |
Dec 15, 2002 Date of Summary:
| Trade name: | AIGIS-PLUS |
|---|---|
| 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 56 510(k) number: K893568
SUMMARY OF THE TECHNOLOGICAL CHARACTERISTICS
Test methods applied: as in ANSI/ADA 5 and ISO 9693
Comparison of composition:
| COMFUSHIUN (WEIGHT, % | ||||||||
|---|---|---|---|---|---|---|---|---|
| Cevice Name | 16 | R/In | ||||||
| ARGENCO | ||||||||
| 50 | VIV | ﻟﻠﺘﻌﻠﻴﻤﺎﺕ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤ | ||||||
| AIGIS " | 10.6 | 05 | ﺎﺕ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟ |
COMPOSITION (WEIGHT %)
Comparison of physical and mechanical properties:
| Alloy | Melting Point Range (°F) | Hardness
(Vickers) | Yield
Strength
(MPa) | Elongation
(%) | Density
(g/cm3) |
|------------|--------------------------|-----------------------|----------------------------|-------------------|--------------------|
| ARGENCO 56 | 1,600-1,710 | 186 | 372 | 38 | 13.6 |
| AIGIS-PLUS | 1,690-1,742 | 154 | 300 | 15 | 13.7 |
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Discussion:
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.
Coriclusion:
The main elements and their concentration are almost identical. AIGIS-PLUS is an inlay, onlay, crown and bridge alloy. This device is dependable 56% gold alloy with a high gold appearance. AIGIS-PLUS is excellent for inlays, three-quarter crowns, long and short-span bridges. AIGIS-PLUS is substantially equivalent to ARGENCO 56 and the minor differences between them do not affect safety or effectiveness.
2
Image /page/2/Picture/1 description: The image is a circular logo for the U.S. Department of Health & Human Services. The logo features the department's name encircling a stylized symbol. The symbol consists of three abstract human profiles facing right, with flowing lines suggesting movement or connection. The profiles are stacked vertically, creating a sense of depth and unity.
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: K024135
Trade/Device Name: AIGIS-PLUS 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 yours.
Susan Runore
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
SE LUCIUS,INC. 9778 Katella Ave. Ste. 205, Anaheim, CA 92804
Phone: (714) 530-2814, Fax : (714) 530-3448,
INDICATIONS FOR USE
510(K) Number : ______________________________________________________________________________________________________________________________________________________________
Device Name(s) : AIGIS-PLUS
AIGIS-PLUS 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(OED)
Me advh ta MSR
nesthesiology, General Hospital, Infection Control, Dental Devic
510(k) Number.__K