(82 days)
Not Found
No
The description focuses on the material properties and intended uses of a dental alloy, with no mention of AI or ML.
No
The device is described as a "platinum-free crown and bridge alloy" intended for manufacturing dental prosthetics, which are materials or components used in treatments, not devices that directly provide therapy.
No
This device is described as a "platinum-free crown and bridge alloy" intended for manufacturing dental prosthetics like inlays, onlays, and bridges. Its description and performance studies focus on physical and mechanical properties, not on diagnosing medical conditions.
No
The device description clearly states it is a "platinum-free crown and bridge alloy," which is a physical material, not software.
Based on the provided information, the LUCIUS 62 device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that LUCIUS 62 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 a sample taken from the body.
- Device Description: The description confirms it's a "platinum-free crown and bridge alloy," further reinforcing its use as a material for creating dental prosthetics.
- Lack of IVD Characteristics: The description does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological samples (blood, urine, tissue, etc.)
- Detecting or measuring substances in biological samples
- Providing information for diagnosis, monitoring, or screening of diseases or conditions.
The information provided describes a material used in the creation of medical devices (dental restorations), not a diagnostic test.
N/A
Intended Use / Indications for Use
LUCIUS 62 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
Not Found
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:
- Jel-62
- LUCIUS 62
Comparison of physical and mechanical properties:
- Jel-62: Melting Point Range(°F) 1,598-1,724, Hardness(Vickers) 170, Yield Strength(psi) 42,000, Elongation(%) 45.0, Density(g/cm3) 14.3
- Lucius 62: Melting Point Range(°F) 1,652-1,710, Hardness(Vickers) 150, Yield Strength(psi) 40,600, Elongation(%) 33.1, Density(g/cm3) 14.1
Conclusion:
The main elements and their concentration are almost identical. LUCIUS 62 is a platinum-free crown and bridge alloy. This device is dependable 62% gold alloy with a high gold appearance. LUCIUS 62 is excellent for inlays, three-quarter crowns, long and short-span bridges. LUCIUS 62 is substantially equivalent to JELENKO'S Jel-62, and the minor differences between them do not affect safety or effectiveness.
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
SEP = 3 2002
510(K) SUMMARY OF STATEMENT
Lucius Metals Com. Submitter of 510(k): 4241 Farquhar Ave. #2, Los Alamitos, CA 90720 Phone/Fax: (562) 799-6626, Cell: (562) 477-0155
| Contact person: | Dae Kyu Chang |
|---|---|
| Phone: | (562) 799-6626 |
| Fax: | (562) 799-6626 |
| E-mail: | Gatorkr@yahoo.co.kr |
Date of Summary: June 5, 2002
| Trade name: | LUCIUS 62 |
|---|---|
| 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: Jel-62 510(k) number: K874308
Test methods applied: as in ANSI/ADA 5 and ISO 9693
Comparison of composition:
| | 101 ·
iul | Pt(% | 1 / 0 / 0 / 1 / 0 / 1 / 0 / 0 / 0 / 0 / 0 / 0 / 0 / 0 / 0 / 0 / 0 / 0 / 0 / 0 / 0 / 0 / 0 / 0 / 0 / 0 / 0 / 0 / 0 / 0 / 0 / 0 / 0 / 0 / 0 / 0 / 0 / 0 / 0 / 0 / 0 / 0 / 0 / 0
10 | ~101 | 101
oul |
|------------------|--------------|------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------|------------|
| -60
lel-UL | 00 00 | 0.00 | 3.00 | 06
20. | 3.0 |
| ે જિ
_ucius & | ۵۹ ۱۳۹ | 0.00 | 500 | 26.00 | |
Comparison of physical and mechanical properties:
| Alloy | Melting Point
Range(°F) | Hardness
(Vickers) | Yield Strength
(psi) | Elongation
(%) | Density
(g/cm3) |
|-----------|----------------------------|-----------------------|-------------------------|-------------------|--------------------|
| Jel-62 | 1,598-1,724 | 170 | 42,000 | 45.0 | 14.3 |
| Lucius 62 | 1,652-1,710 | 150 | 40,600 | 33.1 | 14.1 |
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.
1
Conclusion:
The main elements and their concentration are almost identical. LUCIUS 62 is a platinum-free crown and bridge alloy. This device is dependable 62% gold alloy with a high gold appearance. LUCIUS 62 is excellent for inlays, three-quarter crowns, long and short-span bridges. LUCIUS 62 is substantially equivalent to JELENKO'S Jel-62, and the minor differences between them do not affect safety or effectiveness.
Statement of indication for use:
LUCIUS 62 is intended for manufacturing
- Inlay / Onlays ・
- Crowns -
- Short span bridges -
- -Long span bridges
- Removable partials -
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 a stylized eagle with three stripes forming its body and wings. The eagle is enclosed in a circle, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is written around the top half of the circle. The text is in all capital letters and is evenly spaced around the curve of the circle.
Food and Drug Administration -9200 Corporate Boulevard Rockville MD 20850
SEP - 3 2002
Mr. Dae Kyu Chang President Lucius Metals Company 4241 Farquhar Avenue, # 2 Los Alamitos, California 90720
Re: K021948
Trade/Device Name: LUCIUS 62 Regulation Number: 872.3060 Regulation Name: Gold-Based Alloys and Precious Metal Alloys for Clinical Use Regulatory Class: II Product Code: EJT Dated: June 5, 2002 Received: June 13, 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.
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.
3
Page 2 - Mr. Chang
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 and additionally 21 CFR Part 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4613. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained 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,
Timothy A. Ulatowski
Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Kuz1948
STATEMENT OF INDICATION FOR USE
LUCIUS 62 is intended for manufacturing:
- Inlay / Onlays -
- Crowns -
- Short span bridges -
- Long span bridges -
- Removable partials -
Susa Runges
(Division Sign-Off) Division of Anesthesiology, General Hospital,
Infection Control, Dental Devices
510(k) Number: K021941