The provided text describes a 510(k) premarket notification for a dental casting alloy named CERANUM 50. It aims to demonstrate substantial equivalence to a predicate device, DEGUBOND 4.

Here's an analysis of the requested information based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria for CERANUM 50 are based on demonstrating substantial equivalence in composition and physical/mechanical properties to the predicate device, DEGUBOND 4, as defined by ANSI/ADA 5 and ISO 9693 standards. The device's performance is reported in direct comparison to the predicate device.

Property / Criterion (Derived from Predicate)	Acceptance Range (Implicit, based on Predicate)	Reported Device Performance (CERANUM 50)
Composition (Weight, %)
Au (%)	~49.60%	50.00%
Pt (%)	0.00%	0.00%
Pd (%)	~29.00%	25.00%
Ag (%)	~17.5%	18.0%
Sn (%)	~3.0%	2.0%
Physical and Mechanical Properties
Melting Point Range (°F)	2,120-2,336	2,008-2,079
Hardness (Vickers)	~250	240
Yield Strength (MPa)	~550	450
Elongation (%)	~11.0	16.0
CTE (x10-6/°C)	~14.5	14.2
Density (g/cm³)	~14.5	13.9

Study Proving Acceptance:
The study that proves the device meets the acceptance criteria is a comparative study against the legally marketed predicate device, DEGUBOND 4. This comparison is conducted by evaluating the composition (by weight %) and several physical and mechanical properties according to recognized standards (ANSI/ADA 5 and ISO 9693). The "Discussion" section explicitly states, "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." The "Conclusion" further asserts that "The main elements and their concentration are almost identical" and "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. Sample Size Used for the Test Set and Data Provenance

Sample Size for Test Set: The document does not specify the sample size for the individual tests (e.g., how many samples were tested for hardness, melting point, etc.). It only presents single values for each property.
Data Provenance: The document does not explicitly state the country of origin of the data or whether it was retrospective or prospective. It only mentions that the tests were conducted "as in ANSI/ADA 5 and ISO 9693," which are international standards.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications

This type of study does not involve expert-established ground truth in the traditional sense of medical image analysis or clinical diagnosis. The "ground truth" here is the measured properties of the materials themselves, evaluated against established material standards and the properties of a known predicate device. Therefore, information about the number or qualifications of experts for ground truth establishment is not applicable and not provided in the document.

4. Adjudication Method for the Test Set

Not applicable. This is a material testing study, not a clinical study requiring human adjudication of results. The "adjudication" is inherent in the measurement methods defined by the standards (ANSI/ADA 5 and ISO 9693).

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

No, an MRMC comparative effectiveness study was not done. This study is a material science comparison, not a clinical performance study involving human readers and interpretations.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

Not applicable. This is a material science assessment, not an algorithm-based device.

7. The Type of Ground Truth Used

The "ground truth" in this context is the measured physicochemical and mechanical properties of the CERANUM 50 alloy, compared directly against the known properties of the legally marketed predicate device (DEGUBOND 4) and against the specifications outlined in relevant industry standards (ANSI/ADA 5 and ISO 9693). There is no "expert consensus," "pathology," or "outcomes data" in the typical medical device sense. The ground truth for the comparison is the measured data for both the new and predicate device.

8. The Sample Size for the Training Set

Not applicable. This type of material comparison study does not involve a "training set" in the context of machine learning or AI.

9. How the Ground Truth for the Training Set Was Established

Not applicable, as there is no "training set" for this type of material comparison study.

Summary

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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 forclinical 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	MeltingPointRange (°F)	Hardness(Vickers)	YieldStrength(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

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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.

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.

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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.

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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

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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

Regulation Number and Section

§ 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.