(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, AIGIS-PT, is described as an alloy used for manufacturing dental prosthetics like inlays, onlays, crowns, and bridges, which are restorative devices, not therapeutic devices. Therapeutic devices are typically used to treat or cure a disease or condition, whereas this is a material for fabricating replacements for parts of teeth.
No
Explanation: The device is described as an alloy used for manufacturing dental prosthetics like inlays, onlays, crowns, and bridges. It does not perform any diagnostic function.
No
The device description clearly states that AIGIS-PT 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-PT is "intended for manufacturing" dental restorations like inlays, onlays, crowns, and bridges. This is a manufacturing material used in the body, not a test performed on samples taken from the body.
- Device Description: The description confirms it's a "gold alloy" used for creating these dental restorations.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples, detecting substances, or providing diagnostic information. The performance studies mentioned relate to material properties (as per ANSI/ADA and ISO standards), not diagnostic accuracy.
IVDs are devices used to examine specimens derived from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening. AIGIS-PT is a material used to create a medical device (dental restoration) that is placed in the body.
N/A
Intended Use / Indications for Use
AIGIS-PT is intended for manufacturing
- Inlay / Onlays
- Crowns
- Short span bridges
- Long span bridges
- Removable partials
Product codes
EJT
Device Description
AIGIS-PT is an inlay, onlay, crown and bridge alloy. This device is dependable 77% 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 (study type, sample size, AUC, MRMC, standalone performance, key results)
Comparison of composition and physical/mechanical properties to a legally marketed predicate device (AUROFLUID 2PF). Key results indicate that the main elements and their concentration are almost identical, and minor differences in properties do not affect safety or effectiveness.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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
K0241444
510(K) SUMMARY
MAR 0 7 2003
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 |
Dec 15, 2002 Date of Summary:
| Trade name: | AIGIS-PT |
|---|---|
| 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: AUROFLUID 2PF 510(k) number: K944572
SUMMARY OF THE TECHNOLOGICAL CHARACTERISTICS
Test methods applied: as in ANSI/ADA 5 and ISO 9693
Comparison of composition:
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Comparison of physical and mechanical properties:
| Alloy | Melting Point Range (°F) | Hardness (Vickers) | Yield Strength (MPa) | Elongation (%) | Density (g/cm3) |
|---|---|---|---|---|---|
| AUROFLUID 2PF | 1,705-1,768 | 125 | 260 | 40 | 16.0 |
| AIGIS-PT | 1,807-1,868 | 143 | 220 | 33 | 16.3 |
1
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.
Conclusion:
The main elements and their concentration are almost identical. AIGIS-PT is an inlay, onlay, crown and bridge alloy. This device is dependable 77% gold alloy with a high gold appearance. AIGIS-PT is excellent for inlays, three-quarter crowns, long and short-span bridges. AIGIS-PT is substantially equivalent to AUROFLUID 2PF and the minor differences between them do not affect safety or effectiveness.
2
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of an eagle with its wings spread.
MAR 0 7 2003
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Mr. Dae-Kyu Chang SB LUCIUS, Incorporated 9778 Katella Avenue. Suite 205 Anaheim, California 92804
Re: K024144
Trade/Device Name: AIGIS-PT 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 vour 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.
3
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 (QS) 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 Runner
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 : _
Device Name(s) : AIGIS-PT
AIGIS-PT 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)
Robert Betz DDS for D.K. Mulby
(Division Sign Off)
Division of Anesthesiology, General Hospital,
Infection Control, Dental Devices
510(k) Number. K024144