(80 days)
Not Found
No
The device description and performance studies focus on the material properties of a dental alloy, with no mention of software, algorithms, or AI/ML capabilities.
No
The device is an alloy used for manufacturing dental prosthetics like inlays, onlays, crowns, and bridges, not a device that directly treats a condition or disease.
No
The document describes NEO 76 as an alloy for manufacturing dental restorations like inlays, onlays, crowns, and bridges. It does not mention any function related to diagnosing medical conditions.
No
The device description clearly states it is an "inlay, onlay, crown and bridge alloy," which is a physical material, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that NEO 76 is for manufacturing dental restorations (inlays, onlays, crowns, bridges, removable partials). These are devices used in the body, not for testing samples from the body.
- Device Description: The description confirms it's a dental alloy used for creating these restorations.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples, detecting substances, or providing diagnostic information.
IVD devices are used to examine specimens derived from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening. NEO 76 does not fit this description.
N/A
Intended Use / Indications for Use
NEO 76 is intended for manufacturing
- Inlay / Onlays -
- Crowns -
- Short span bridges -
- Long span bridges -
- Removable partials -
Product codes
EJT
Device Description
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.
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
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 |
Key results: The main elements and their concentration are almost identical. 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. NEO 76 is substantially equivalent to ARGENCO 77 and the minor differences between them do not affect safety or effectiveness.
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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.
0
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 for |
| clinical 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 |
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:
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.
2
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.
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 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
4
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: