CERANUM 82 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 82 is a high gold ceramic alloy, which heightens the porcelain esthetics of the restoration and provides strength, durability and color of gold.

AI/ML Overview

The provided text describes a 510(k) premarket notification for a dental casting alloy, Ceranum 82, and its substantial equivalence to a predicate device, Metalor's V-Supragold. This is a material comparison, not a medical device involving AI, image analysis, or clinical performance studies in the way the request implies. Therefore, many of the requested fields are not applicable.

Here's the relevant information extracted and presented:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria are implicitly defined by the properties of the predicate device, Metalor's V-Supragold, and relevant industry standards (ANSI/ADA 5 and ISO 9693). The device (Ceranum 82) meets these criteria by demonstrating comparable physical and mechanical properties within acceptable ranges. The "acceptance" is based on showing substantial equivalence rather than meeting strict predefined thresholds for a new clinical outcome.

Acceptance Criteria (Predicate Device - V-Supragold)	Reported Device Performance (Ceranum 82)
Composition (Weight %)
Au: 83.00%	Au: 82.00%
Pt: 8.8%	Pt: 8.87%
Pd: 5.20%	Pd: 3.8%
In: 2.8%	In: 2.0%
Ir: <1.0%	Ir: 0.1%
Ta: <1.0%	Ta: 0.25%
Physical and Mechanical Properties
Melting Point Range: 2,012-2,210 °F	Melting Point Range: 2,192-2,372 °F
Hardness (Vickers): 190	Hardness (Vickers): 165
Yield Strength (MPa): 425	Yield Strength (MPa): 320
Elongation (%): 7.0	Elongation (%): 9.3
CTE (x10-6/°C): 14.3	CTE (x10-6/°C): 14.1
Density (g/cm³): (Not reported for predicate)	Density (g/cm³): 19.2

Note: The discussion explicitly states, "The main elements and their concentration are almost identical," and "Despite minor differences in the materials, we believe that CERAUM 82 is a substantially equivalent to Metalor's V-Supragold. These changes do not affect safety or effectiveness." This implies that the observed differences are deemed acceptable within the context of substantial equivalence.

Regarding the Study:

The study proving the device meets the acceptance criteria is a bench testing/laboratory comparison study against a legally marketed predicate device, using established industry standards.

Test methods applied: ANSI/ADA 5 and ISO 9693.

2. Sample size used for the test set and the data provenance: Not applicable. This is a material characterization rather than a clinical study with patients or a dataset for an algorithm. The "test set" would refer to the samples of the Ceranum 82 alloy that underwent the physical and chemical tests. The document does not specify the number of material samples tested.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. This is a material science characterization; ground truth is established by standardized measurements of chemical composition and physical properties rather than expert consensus on interpretive data.

4. Adjudication method for the test set: Not applicable. Material properties are measured, not adjudicated by human readers.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance: Not applicable. This document pertains to a dental alloy, not an AI-powered diagnostic or assistive device.

6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: Not applicable. This is not an algorithm or AI device.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): The ground truth for this device involved standardized laboratory measurements of chemical composition and physical/mechanical properties in accordance with industry standards (ANSI/ADA 5 and ISO 9693), and comparison to the known properties of a predicate device.

8. The sample size for the training set: Not applicable. This is not an AI or machine learning device.

9. How the ground truth for the training set was established: Not applicable. No training set is involved for this type of device submission.

Summary

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5 2002 NOV

K023197

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:Common:Classification name:	CERANUM 82Dental casting alloyGold based alloys and precious metal alloys forclinical use
Product code:	EJT
Classification:	Class II

Legally marketed device: Metalor's V-Supragold 510(k) number: K993508

SUMMARY OF THE TECHNOLOGICAL CHARACTERISTICS

Test methods applied: as in ANSI/ADA 5 and ISO 9693

Comparison of composition:

Device Name	Au (%)	Pt (%)	Pd (%)	In (%)	Ir	Ta
V-Supragold	83.00	8.8	5.20	2.8	<1.0%	<1.0%
Ceranum 82	82.00	8.87	3.8	2.0	0.1	0.25

COMPOSITION (WEIGHT, %)

Comparison of physical and mechanical properties:

Alloy	Melting Point Range (°F)	Hardness (Vickers)	Yield Strength (MPa)	Elongation (%)	CTE (x10-6/°C)	Density (g/cm3)
V-Supragold	2,012-2,210	190	425	7.0	14.3
Ceranum 82	2,192-2,372	165	320	9.3	14.1	19.2

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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 82 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 82 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 82 is a substantially equivalent to Metalor's V-Supragold . These changes do not affect safety or effectiveness.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

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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: K023197

Trade/Device Name: Ceranum 82 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

5 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.

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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 (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

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9778 Katella Ave.

Ste, 205, Anaheim, CA 92804

Phone: (714) 530-28

INDICATIONS FOR USE

510(K) Number : K023197

Device Name(s) : ceranum 82

CERANUM 82 is intended for manufacturing:

Single Crown -
Bridges -
Implant superstructures

(PLEASE DO NOT WRITE BELOW THIS LINE CONTINUE ON ANOTHER PAGE IF NEEDED)

CONCURRENCE OF CHRD,OFFICE OF DEVICE EVALUATION(OED)

K.Schatz DDE/for Div. S. Kummer
(Division Sign Off)

Division of Anesthesiology, General Hospital, tion Control, Dental De

510(k) Number. KC23197

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.