(48 days)
Not Found
Not Found
No
The 510(k) summary describes dental alloys and their intended uses, with no mention of software, algorithms, or any technology related to AI or ML.
No
The device descriptions indicate that these are dental alloys used for restorative purposes, such as crowns and bridges, rather than for treating a disease or condition.
No
The provided text describes dental alloys used for restorations (crowns, bridges, etc.), which are materials used in treatment, not for diagnosing medical conditions.
No
The intended use describes dental alloys, which are physical materials, not software. The document provides no information about any software component.
Based on the provided information, these devices are not IVDs (In Vitro Diagnostics).
Here's why:
- Intended Use: The intended use clearly describes these devices as materials (porcelain to precious metal alloys) used for creating dental prosthetics like crowns, bridges, and implant structures. This is a restorative or prosthetic application, not a diagnostic one.
- Lack of Diagnostic Function: There is no mention of these devices being used to test samples (blood, urine, tissue, etc.) or to provide information about a patient's health status or disease.
- Device Description: While the device description is "Not Found," the intended use is the primary indicator of whether a device is an IVD.
- Other Sections: The absence of information in sections like "Mentions image processing," "Mentions AI, DNN, or ML," "Input Imaging Modality," "Anatomical Site," "Indicated Patient Age Range," "Intended User / Care Setting," and performance study details further supports that these are not diagnostic devices.
In summary, these STARBOND products are materials used in the fabrication of dental restorations, which falls under the category of medical devices, but not specifically In Vitro Diagnostic devices.
N/A
Intended Use / Indications for Use
STARBOND SISG: Porcelain to precious metal alloy suitable for single units, short and long span bridges for metal ceramics, as well as milled work and implant over structures.
STARBOND S250: Porcelain to precious metal alloy suitable for single units, short and long span bridges for metal ceramics, as well as milled work and implant over structures.
STARBOND 575P: Porcelain to precious metal alloy suitable for single units, short and long span bridges for metal ceramics, as well as milled work, bars and attachments and cast partial dentures.
STARBOND 650SF: Porcelain to precious metal alloy suitable for single units, short and long span bridges for metal ceramics, as well as implant over structures.
STARBOND 780G: Porcelain to precious metal alloy suitable for a wide range of applications including: single units, short and long span bridges for metal ceramics and milled work and implant over structures.
STARBOND 860G: Porcelain to precious metal alloy surface for Single surface intact inlays, crowns, small and long span bridges as well as crown and bridge fromes for metal ceramics
STARBOND 990G: Poroclain to precious metal alloy suitable for low stress stuations only, single units with till porcelain coverage.
Product codes
EJT, EJS
Device Description
Not Found
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Not Found
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
Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an emblem featuring a stylized depiction of a human figure with outstretched arms, overlaid with three horizontal bars.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Star Refining Precious Metals South Africa C/O Mr. Ned E. Devine Responsible Third Party Official Entela, Incorporated Engineering and Testing Laboratories 3033 Madison Avenue, SE Grand Rapids, Michigan 49548
Re: K032106
Trade/Device Name: StarBond Dental Bonding Alloys Regulation Number: 872.3060 Regulation Name: Gold-Basted Alloys and precious Metal Alloys for Clinicial Use Regulatory Class: II Product Code: EJT, EJS Dated: August 8, 2003 Received: August 11, 2003
Dear Mr. Devine:
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.
AUG 2 5 2003
1
Page 2 – Mr. Divine
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 (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), 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 Kurner
Susan Runner, DDS, MA Interim Direction Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
510(k) Number (if known):
Device Name: Starbond Dental Alloys
Classification Panel: 872.3060 EJT
Indications for Use:
STARBOND SISG
Porcelain to precious recal ulloy suitable for single units, short and long span bridges for metal ceramics, as well as milled work and implant over structures.
STARBOND S250
Porcelain to precious metal alloy suitable for single units, short and long span bridges for metal ceramics, as well as milled work and implant over structures.
STARBOND 575P
Porcelain to precious metal alloy suitable for single units, short and long span bridges for metal commics, as well as milled work, bars and attachments and cast partial dentures.
STARBOND 650SF
Porcelain to precious metal alloy suitable for single units, short and long span bridges for metal ceramics, as well as implant over structures.
STARBOND 780G
Porcelain to presious metal alloy suitable for a wide range of applications including: single units, short and long span bridges for metal ccramics and milled work and implant over structures.
STARBOND 860G
Porcelain to precious metal alloy surface for Single surface intact inlays, crowns, small and long span bridges as well as crown and bridge fromes for metal ceramics
STARBOND 990G
Poroclain to precious metal alloy suitable for low stress stuations only, single units with till porcelain coverage.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use
or
Over the Counter Use _________________________________________________________________________________________________________________________________________________________
Susan Runn
(Division Sign-Off) Division of Anesthesiology, General Hospital, Infection Control, Dental Devices
510(k) Number: K083211