(40 days)
Not Found
No
The 510(k) summary describes a ceramic alloy for dental prosthetics and does not mention any AI or ML components.
No.
The "Intended Use" states that the device is for single unit, implants prosthetics, single & 3/4 crowns, and short span bridges, which are restorative dental products, not inherently therapeutic devices.
No
The device is described as a ceramic alloy for various dental prosthetics (single unit, implants, crowns, bridges), which are restorative and not diagnostic in nature.
No
The intended use describes a physical ceramic alloy for dental prosthetics, which is a hardware component, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use describes a ceramic alloy for dental prosthetics (crowns, bridges, etc.). This is a material used in the body or on the body, not for testing samples from the body to diagnose or monitor a condition.
- Device Description: While "Not Found" for the description, the intended use clearly places it outside the realm of in vitro diagnostics.
- Other Sections: The absence of information in sections like "Mentions image processing," "Mentions AI, DNN, or ML," "Input Imaging Modality," "Anatomical Site," "Indicated Patient Age Range," "Intended User / Care Setting," and performance study details further supports that this is not an IVD. IVDs typically involve analyzing biological samples and would have data related to their analytical and clinical performance.
- Predicate Device: The predicate device, K905387 (DEGUBOND 4), is also a dental alloy, reinforcing the classification of this device as a dental material, not an IVD.
In summary, the intended use and the nature of the device as a ceramic alloy for dental restorations clearly indicate that it is not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
This is a yellow ceramic alloy for single unit, implants prosthetics, single & 3/4 crowns, and short span bridges.
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)
Not Found
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
NOV 4 2002
KC023199
510(K) SUMMARY
SB LUCIUS, INC. Submitter of 510(k): Ste, 205, Anaheim, CA 92804 9778 Katella Ave. 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: Sept. 16, 2002
| Trade name: | CERANUM 50 |
|---|---|
| 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: DEGUBOND 4 510(k) number: K905387
SUMMARY OF THE TECHNOLOGICAL CHARACTERISTICS
Test methods applied: as in ANSI/ADA 5 and ISO 9693
Comparison of composition:
COMPOSITION (WEIGHT, %)
| Device | Au (%) | Pt (%) | Pd (%) | AG (%) | SN(%) |
|---|---|---|---|---|---|
| Degubond 4 | 49.60 | 0.00 | 29.00 | 17.5 | 3.0 |
| CERANUM 50 | 50.00 | 0.00 | 25.00 | 18.0 | 2.0 |
Comparison of physical and mechanical properties:
| Alloy | Melting
Point
Range (°F) | Hardness
(Vickers) | Yield
Strength
(MPa) | Elongation
(%) | CTE
(x10-6/°C) | Density
(g/cm3) |
|------------|--------------------------------|-----------------------|----------------------------|-------------------|-------------------|--------------------|
| Degubond 4 | 2,120-2,336 | 250 | 550 | 11.0 | 14.5 | 14.5 |
| CERANUM 50 | 2,008-2,079 | 240 | 450 | 16.0 | 14.2 | 13.9 |
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. CERANUM 50 is a High Noble, Micro-fine, Yellow, Gold based alloy to be used for single crowns, bridge, implant superstructures and substrate for medium expansion with lower fusing porcelains and indirect restorative composites. CERANUM 50 is a high gold ceramic alloy, which heightens the porcelain esthetics of the restoration and provides strength, durability and color of gold. Despite minor differences in the materials, we believe that CERAUM 50 is a substantially equivalent to DEGUSSA AG's DEGUBOND 4. These changes do not affect safety or effectiveness.
2
DEPARTMENT OF HEALTH & HUMAN SERVICES
ood and Drug Administratio 200 Corporate Boulevaro Rockville MD 20850
NOV 4 2002
Mr. Dae-Kyu Chang SB Lucius, Incorporated 9778 Katella Avenue, Suite 205 Anaheim, California 92804
Re: K023199
Trade/Device Name: Ceranum 50 Regulation Number: 21 CFR 872.3060 Regulation Name: Gold-Based Alloys and Precious Metal Alloys for Clinical Use Regulatory Class: II Product Code: EJT Dated: September 16, 2002 Received: September 25, 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 Mav 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 (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 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
Timothy Ulatowski Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
9778 Katella Ave.
- Anaheim, CA 9
Phone: (714) 530-2814,
Fax : (714) 530-3448,
INDICATIONS FOR USI
510(K) Number : K023199
Device Name(s) : ceranum 50
This is a yellow ceramic alloy for single unit, implants prosthetics, single & 3/4 crowns, and short span bridges.
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CONCURRENCE OF CHRD,OFFICE OF DEVICE EVALUATION(OED)
Susan Dunne
Division Sian-Off) ion of Anesthesiology. General Hospital. Infection Control. Dental Devices
510(k) Number: KC23198