(90 days)
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.
GPW-SF Solder
This is a 510(k) clearance letter for a dental solder, GPW-SF Solder, not a study evaluating a medical device's performance against acceptance criteria. Therefore, I cannot extract the requested information as it is not present in the provided text.
The document indicates that the device is "substantially equivalent" to legally marketed predicate devices for its intended use, which is a regulatory decision rather than a performance study. It states:
- Device Name: GPW-SF Solder
- Intended 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."
The letter does not contain:
- A table of acceptance criteria or reported device performance.
- Information on sample sizes, data provenance, number of experts, adjudication methods, MRMC studies, standalone performance, or ground truth details.
- Any description of a study conducted to demonstrate the device meets specific performance criteria.
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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:
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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
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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 Infectionand General Hospital Device | |
| 510(k) Number | K011659 |
| Prescription Use(Per 21 CFR 801.109 | OR | Over-the Counter-Use |
|---|---|---|
| ----------------------------------------- | ---- | ---------------------- |
§ 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.