Predicate Devices

Reference Devices

Not Found

AI/ML (Artificial Intelligence / Machine Learning)

No
The summary describes a dental casting alloy and its physical/mechanical properties, with no mention of AI or ML.

Therapeutic

No
The device is a dental casting alloy used for manufacturing dental prosthetics, which are inert materials and not actively therapeutic.

Diagnostic

No
The device is described as a "dental casting alloy" intended for manufacturing dental prosthetics like inlays, onlays, and crowns, which are restorative and prosthetic purposes, not diagnostic.

SaMD (Software as a Medical Device)

No

The device description explicitly states it is a "Dental casting alloy," which is a physical material, not software.

IVD (In Vitro Diagnostic)

Based on the provided information, this device is not an IVD (In Vitro Diagnostic).

Here's why:

Intended Use: The intended use is for manufacturing dental restorations (inlays, onlays, crowns, bridges, partials). This is a structural/restorative purpose within the body, not for testing samples taken from the body to diagnose or monitor a condition.
Device Description: It's described as a "Dental casting alloy," which is a material used in the fabrication of dental devices.
Lack of IVD Characteristics: The description lacks any mention of:
- Analyzing samples (blood, urine, tissue, etc.)
- Detecting or measuring substances in samples
- Providing diagnostic information
- Using reagents or calibrators

The information provided clearly indicates a device used for fabricating dental prosthetics, which falls under the category of dental materials or devices, not in vitro diagnostics.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

AIGIS-INLAY is intended for manufacturing

Inlay / Onlays -
Crowns -
Short span bridges -
Long span bridges -
Removable partials

Product codes

EJT

Device Description

AIGIS-INLAY is an inlay, onlay, crown and bridge alloy. This device is dependable 88% gold alloy with a high gold appearance. AIGIS-INLAY is excellent for inlays, three-quarter crowns, long and short-span bridges.

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

The main elements and their concentration are almost identical. AIGIS-INLAY is substantially equivalent to DEGULOR A and the minor differences between them do not affect safety or effectiveness. Test methods applied: as in ANSI/ADA 5 and ISO 9693.

Key Metrics

A comparison of physical and mechanical properties was provided:

Alloy	Melting Point Range (°F)	Hardness (Vickers)	Yield Strength (MPa)	Elongation (%)	Density (g/cm3)
DEGULOR A	1,912-2,002	55	80	45	17.2
AIGIS-INLAY	1,922-2,002	60	85	45	17.2

Predicate Device(s)

K951786

Reference Device(s)

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information

Not Found

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.

Summary

0

K024139

MAR 0 7 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

Dec 15, 2002 Date of Summary:

Trade name:	AIGIS-INLAY
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: DEGULOR A 510(k) number: K951786

SUMMARY OF THE TECHNOLOGICAL CHARACTERISTICS

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

Comparison of composition:

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| | | Call Concession Concession Come | ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ | STALL-FECTLE ST | and and and the designed of the distribution of the distribution of | A A S A S A C S S S S S S S S S S S S S S S S S S S S S S S S S S S S S S S S S S S S S S S S S S S S S S S S S S S S S S S S S S S S S S S S S S S S S S S S S S S S S S S S |
| STATE TO COLLALLE LABOR
P. Participant and management and the discussion and the discussion of | A C T S S S S P P S ST P S ST P S S P S P S P S P S P S P S P S P S P S P S P S P S P S P S P S P S P S P S P S F O L P S P O F T L P O F T L P O F T L P O F T L T L L F S T | an annual any a characterial consumeration control controlled controlled controlled controlled controlled controlled controlled controlled controlled controlled controlled co | 1 M 11 11 11 11 11 11 11 11 11 11 11 11 11 11 11 11 11 11 11 11 11 11 11 11 11 11 11 11 11 | . | | the start and proposition and the a seat of the a new |
| A . A F A L L . L
К. С. С. С. С. С. С. С. С. С. С. С. С. С. С. С. С. С. С. С. С. С. С. С. С. С. С. С. С. С. С. С. С. С. С. С. С. С. С. П. П. П. П. П. П. П. П. П. П. П. П. П. П. П. П. П. П. П. | and and the can and a compression of the first of the commended | | | приводу с седание содаренности и в седениемов в местите в пристемето в поставления в селото в седент у уступи у уступи у уступить и по | | |

COMPOSITION WEICHT W

Comparison of physical and mechanical properties:

Alloy	Melting Point Range (°F)	Hardness (Vickers)	Yield Strength (MPa)	Elongation (%)	Density (g/cm3)
DEGULOR A	1,912-2,002	55	80	45	17.2
AIGIS-INLAY	1,922-2,002	60	85	45	17.2

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:

-"he main elements and their concentration are almost identical. AIGIS-INI.AY is an inlay, onlay, crown and bridge alloy. This device is dependable 88% gold alloy with a high gold appearance. AIGIS-INLAY is excellent for inlays, three-quarter crowns, long and short-span bridges. AIGIS-INLAY is suostantially equivalent to DEGULOR A and the minor differences between them do not affect safety or effectiveness.

2

Image /page/2/Picture/1 description: The image is a black and white seal for the Department of Health & Human Services - USA. The seal is circular with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of an eagle with three human profiles incorporated into its design.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MAR 0 7 2003

Mr. Dae-Kyu Chang SB LUCIUS, Incorporated 9778 Katella Avenue, Suite 205 Anaheim, California 92804

Re: K024139

Trade/Device Name: AIGIS-INLA Y 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, 2002 Received: December 16, 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.

3

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 vours.

Susan Runner

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

4

naheim, CA 92804

Phone: (714) 530-2814, Fax : (714) 530-3448,

INDICATIONS FOR USE

510(K) Number : K024139

Device Name(s) : AIGIS-INLAY

AIGIS-INLAY 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)

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oncurrence of chrd,office of device evaluation(oed)

K024139 KB for Drk. Muly
(Division Sign-Off)
Division of Anesthesiology Conomi Hospital

Division of Anesthesiology, General Hospital
Infection Control, Dental Devices

510(k) Number: K024