NEO 76 is an inlay, onlay, crown and bridge alloy. This device is dependable 76% gold alloy with a high gold appearance. NEO 76 is excellent for inlays, threequarter crowns, long and short-span bridges.

AI/ML Overview

The provided text describes the 510(k) summary for the dental casting alloy, NEO 76. This submission aims to prove substantial equivalence to a predicate device, ARGENCO 77, rather than establishing acceptance criteria and conducting a study to meet them in the traditional sense of a performance study measuring clinical outcomes.

Instead, the "acceptance criteria" here relate to the demonstration of similar technological characteristics to the predicate device, thereby inferring similar safety and effectiveness. The "study" refers to the comparison of composition, physical, and mechanical properties between the new device (NEO 76) and the predicate device (ARGENCO 77).

Here's an analysis based on the provided information:

1. A table of acceptance criteria and the reported device performance

Since this is a substantial equivalence submission for a material, the "acceptance criteria" are implied to be the ranges and values of the predicate device's properties. The new device's performance is then compared to these.

Characteristic	Acceptance Criteria (Predicate: ARGENCO 77)	Reported Device Performance (NEO 76)
Melting Point Range	1,695 - 1,760 (°F)	1,784 - 1,840 (°F)
Hardness (Vickers)	105	148
Yield Strength (MPa)	214	270
Elongation (%)	36	48
Density (g/cm3)	15.9	16.1
Composition	"almost identical" to ARGENCO 77 (implied)	"almost identical" to ARGENCO 77 (implied)

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

The document does not specify sample sizes for testing or data provenance. The data presented are likely from laboratory tests conducted on the materials. It's a technical comparison of material properties, not a clinical study involving patients.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

This section is not applicable. The "ground truth" for material properties is established by standardized testing methods (ANSI/ADA 5 and ISO 9693), not by expert consensus on clinical cases.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

This section is not applicable. Adjudication methods are typically for clinical case review, not for material property testing.

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

There was no MRMC comparative effectiveness study. This device is a dental casting alloy, not an imaging device or AI-assisted diagnostic tool.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

This section is not applicable. This is a material, not an algorithm.

7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)

The "ground truth" for the comparison is established by standardized material testing methods (ANSI/ADA 5 and ISO 9693) for physical and mechanical properties. For composition, elemental analysis would be used.

8. The sample size for the training set

This section is not applicable. There is no "training set" in the context of material property comparison for substantial equivalence.

9. How the ground truth for the training set was established

This section is not applicable. There is no "training set" or corresponding ground truth establishment in this type of submission.

Summary of the Study (Comparison for Substantial Equivalence):

The study conducted was a technical comparison of compositional and physical/mechanical properties between the new device (NEO 76) and a legally marketed predicate device (ARGENCO 77).

Methods: The comparison was based on test methods applied as in ANSI/ADA 5 and ISO 9693. These standards define the procedures for measuring specific material properties like melting point, hardness, yield strength, elongation, and density. Compositional analysis would also have been performed.
Findings: The submitter concluded that "The main elements and their concentration are almost identical" and presented a table comparing key physical and mechanical properties. While there are some numerical differences (e.g., NEO 76 has a slightly higher melting point range, hardness, yield strength, elongation, and density), the submitter's argument for substantial equivalence is based on these differences not affecting safety or effectiveness.
Conclusion for Substantial Equivalence: The FDA's letter (K024141) confirms that the device was found substantially equivalent to the predicate device, indicating that the submitted comparison adequately demonstrated that the minor differences do not raise new questions of safety or effectiveness.

Summary

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K 024141

MAR 0 6 2003

510(K) SUMMARY

Submitter of 510(k): SB LUCIUS, INC. 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

Date of Summary: Dec 15, 2002

Trade name:	NEO 76
Common:	Dental casting alloy
Classification name:	Gold based alloys and precious metal alloys forclinical use
Product code:	EJT
Classification:	Class II

l.egally marketed device: ARGENCO 77 !510(k) number: K893385

SUMMARY OF THE TECHNOLOGICAL CHARACTERISTICS

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

Comparison of composition:

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POSITION WEIGHT W

Comparison of physical and mechanical properties:

Alloy	Melting Point Range (°F)	Hardness (Vickers)	Yield Strength (MPa)	Elongation (%)	Density (g/cm3)
ARGENCO 77	1,695 - 1,760	105	214	36	15.9
NEO 76	1,784-1,840	148	270	48	16.1

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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. NEO 76 is arı inlay, onlay, crown and bridge alloy. This device is dependable 76% gold alloy with a high gold appearance. NEO 76 is excellent for inlays, threequarter crowns, long and short-span bridges. NEO 76 is substantially equivalent to ARGENCO 77 and the minor differences between them do not affect safety or effectiveness.

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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 facing to the right. Encircling the eagle is the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" in a circular arrangement.

MAR 0 6 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: K024141 Trade/Device Name: NEO 76 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, 2003 Received: December 16, 2003

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.

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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 Rumer

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

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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: KC24141

Device Name(s) : NEO 76

NEO 76 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)

Suan Ruse.

ision Sign-Off ivision of Anesthesiology, General Hospital, Infection Control, Dental Devices

510(k) Number:

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.