(81 days)
AIGIS-INLAY is intended for manufacturing
- Inlay / Onlays -
- Crowns -
- Short span bridges -
- Long span bridges -
- Removable partials
Dental casting alloy
This 510(k) summary describes a dental casting alloy, AIGIS-INLAY, and asserts its substantial equivalence to a legally marketed predicate device, DEGULOR A. The acceptance criteria and the study proving it meets these criteria are based on direct comparison of physical and mechanical properties and composition.
Here's a breakdown of the requested information:
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria are established by comparing the AIGIS-INLAY to the predicate device, DEGULOR A, based on specific physical and mechanical properties, and composition. The underlying standard referenced is ANSI/ADA 5 and ISO 9693. Given this is a material comparison for substantial equivalence, the "acceptance criteria" are effectively that the new device's properties are "very similar" or fall within an acceptable range compared to the predicate.
| Property | Acceptance Criteria (based on DEGULOR A) | Reported Device Performance (AIGIS-INLAY) |
|---|---|---|
| Composition | "almost identical" to DEGULOR A | Main elements and their concentration are "almost identical" |
| Melting Point Range (°F) | 1,912-2,002 | 1,922-2,002 |
| Hardness (Vickers) | 55 | 60 |
| Yield Strength (MPa) | 80 | 85 |
| Elongation (%) | 45 | 45 |
| Density (g/cm³) | 17.2 | 17.2 |
Study to Prove Acceptance Criteria:
The study used to prove the device meets the acceptance criteria is a direct comparison of composition and physical/mechanical properties between the AIGIS-INLAY and the predicate device, DEGULOR A. The methods applied are "as in ANSI/ADA 5 and ISO 9693," which are international standards for dental casting alloys. The conclusion reached is that the AIGIS-INLAY is "substantially equivalent" to DEGULOR A, and "minor differences between them do not affect safety or effectiveness."
2. Sample size used for the test set and the data provenance:
- Sample Size: Not specified. The document presents single-point values for each property for both the predicate and the new device. It does not provide information on the number of samples tested to arrive at these values.
- Data Provenance: Not specified. It can be assumed that the data for AIGIS-INLAY was generated by the manufacturer (SB LUCIUS, INC.)
- Retrospective or Prospective: Not applicable as this is a material properties comparison, not a clinical study.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
Not applicable. The ground truth for this device (a dental casting alloy) is established by comparing its physical and mechanical properties against recognized dental material standards (ANSI/ADA 5 and ISO 9693) and a legally marketed predicate device, not by expert consensus on clinical cases.
4. Adjudication method for the test set:
Not applicable. This is a technical comparison of material properties, not a study requiring adjudication of clinical findings or interpretations.
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 casting alloy, not an AI-powered diagnostic device.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
Not applicable. This document pertains to a dental casting alloy, not an algorithm.
7. The type of ground truth used:
The ground truth used is primarily physical and mechanical property measurements as defined by the standards ANSI/ADA 5 and ISO 9693, and chemical composition analysis. The properties of the predicate device (DEGULOR A) serve as the benchmark for substantial equivalence.
8. The sample size for the training set:
Not applicable. This is a device substantial equivalence submission, not a machine learning model.
9. How the ground truth for the training set was established:
Not applicable. This is a device substantial equivalence submission, not a machine learning model.
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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 forclinical 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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| A . A F A L L . LК. 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 |
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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:
-"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.
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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.
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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 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
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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
§ 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.