(90 days)
Not Found
Not Found
No
The device is a dental solder, a material used for brazing. The description focuses on its material properties and intended use in dental prosthetics, with no mention of software, algorithms, or data processing that would indicate AI/ML.
No
The device is a solder used in the manufacturing of dental prosthetics and does not directly interact with the patient for therapeutic purposes.
No
The "Intended Use" states that GPW-SF is a "high fusing white colored gold based solder for brazing porcelain-fused-to-metal alloys prior to the application and firing of the porcelain enamel." This describes a material used in the manufacturing process of dental prosthetics, not a device used to diagnose a medical condition.
No
The device description clearly states it is a "gold based solder," which is a physical material used in manufacturing, 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 GPW-SF is a solder for brazing dental alloys in the manufacture of dental prosthetics (single units, short-span and long-span bridges). This is a manufacturing process for a medical device, not a diagnostic test performed on a biological sample.
- Device Description: The description simply identifies it as a solder.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), detecting specific analytes, or providing diagnostic information about a patient's health status.
IVDs are devices used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. GPW-SF does not fit this description.
N/A
Intended Use / Indications for Use
GPW-SF is a high fusing white colored gold based solder for brazing porcelain-fused-to-metal alloys prior to the application and firing of the porcelain enamel. It is intended for use in the manufacture of single units, short-span and long-span bridges.
Product codes
EJT
Device Description
GPW-SF Solder is a high fusing white colored gold based solder.
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
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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 is circular and contains the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract symbol that resembles an eagle or bird in flight, composed of three curved lines.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
AUG 2 7 2001
Mr. John C. Constantine Secretary/Treasurer Gateway Alloys, Incorporated 1702 Scherer Parkway Saint Charles, Missouri 63303
K011659 Re : GPW-SF Solder Trade/Device Name: Regulation Number: 872.3060 Requlatory Class: II Product Code: EJT Dated: July 6, 2001 Received: August 21, 2001
Dear Mr. Constantine:
We have reviewed your Section 510(k) notification of intent to we nave levice your boosed above and we have determined the market the device forline. (for the indications for device is subscancially ora) to legally marketed predicate use stated in the cholobals, a commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to the enactment accorden reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act), provisions of the reacrar room, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual provisions of the ing 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 (Premarket Approval), it may be subject to such additional controls. Existing major be subject co back addrour device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 895. ದ substantially equivalent determination assumes compliance with Bubbeancearly ogaManufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug chrough periodic go will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory In addition, FDA may publish further announcements action. concerning your device in the Federal Register. Please note:
1
Page 2 - Mr. Constantine
this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic emroduct Radiation Control provisions, or other Federal laws or requlations.
This letter will allow you to begin marketing your device as described in your 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 requlation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4612. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 807.97). Other general information on your responsibilities under the Act may be obtained 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,
Ky Alatriste
Timothy A. Ulatowsk Director Division of Dental, Infection Control and General Hospital Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
KOII 659
(510 (k) Number:
Device Name: GPW -SF Solder __________________________________________________________________________________________________________________________________________________
Indications for Use: GPW-SF is a high fusing white colored gold based solder for
brazing porcelain-fused-to-metal alloys prior to the application and firing of the porcelain
enamel. It is intended for use in the manufacture of single units, short-span and long-
span bridges.
(Please do not write below this line)
| (Division Sign-Off) | |
|---|---|
| Division of Dental Infection | |
| and General Hospital Device | |
| 510(k) Number | K011659 |
| Prescription Use
| (Per 21 CFR 801.109 | OR | Over-the Counter-Use |
|---|---|---|
| ----------------------------------------- | ---- | ---------------------- |