GPW-SF

K011659 · Gateway Alloys, Inc. · EJT · Aug 27, 2001 · Dental

Device Facts

• Record ID: K011659
• Device Name: GPW-SF
• Applicant: Gateway Alloys, Inc.
• Product Code: EJT · Dental
• Decision Date: Aug 27, 2001
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.3060
• Device Class: Class 2

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.

Device Story

GPW-SF Solder is a high-fusing, white-colored, gold-based dental solder. It is used by dental laboratory technicians during the fabrication of dental prosthetics. The solder is applied to porcelain-fused-to-metal (PFM) alloys to braze components together (single units, short-span, or long-span bridges) before the porcelain enamel is applied and fired. The device facilitates the structural assembly of dental restorations.

Technological Characteristics

High-fusing, white-colored, gold-based dental solder. Formulated for brazing porcelain-fused-to-metal alloys in dental laboratory settings.

Indications for Use

Indicated for use in the manufacture of dental restorations, specifically single units, short-span, and long-span bridges, by brazing porcelain-fused-to-metal alloys prior to porcelain enamel application.

Regulatory Classification

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.

Special Controls

*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.

Submission Summary (Full Text)

{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 [phone]. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. 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 [phone] or [phone] 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<br>and General Hospital Device | |
| 510(k) Number | K011659 |

| Prescription Use<br>(Per 21 CFR 801.109 | OR | Over-the Counter-Use |
|-----------------------------------------|----|----------------------|
|-----------------------------------------|----|----------------------|