(66 days)
Used by a dental lab technician, under the direction of an attending dentist, to cast elements of fixed and removable dental prostheses: precious metal bridges, bars, and posts; precious metal copings, pontics and bridges for porcelain-fused-to-metal restorations. For porcelain-fused-to-metal restorations it is intended by the manufacturer that only normal-fusing-temperature porcelain products be used with the Biogold Plus alloy. After fabrication and finishing the completed prosthesis is approved and placed in the patient's mouth by the dentist.
Biogold Plus Dental Alloy
The provided document is a 510(k) premarket notification letter from the FDA regarding a dental alloy named "Biogold Plus Dental Alloy." This document does not contain any information about acceptance criteria or a study proving device performance. It is a regulatory approval letter stating that the device is substantially equivalent to legally marketed predicate devices and outlines the indications for use.
Therefore, I cannot fulfill your request for descriptions of:
- A table of acceptance criteria and reported device performance.
- Sample size and data provenance for a test set.
- Number and qualifications of experts for ground truth.
- Adjudication method.
- MRMC comparative effectiveness study results.
- Standalone algorithm performance.
- Type of ground truth used.
- Sample size for the training set.
- How ground truth for the training set was established.
This information would typically be found in a study report or a different section of a 510(k) submission, and is not present in the provided FDA letter.
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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 consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" around the perimeter. Inside the circle is an abstract symbol that resembles a stylized eagle or bird in flight, composed of three overlapping profiles of human faces.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
APR 2 7 1998
Ms. Gisela N. Everngam Sales Director Official Correspondent European Dental Imports, Incorporated 49 Emerson Road P.O. Box 799 Durham, New Hampshire 03824-0799
Re: K980660 Trade Name: Biogold Plus Dental Alloy Regulatory Class: II Product Code: EJT Dated: February 18, 1998 February 20, 1998 Received:
Dear Ms. Everngam:
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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). 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 (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Requlations, Title 21, Parts 800 to 895. ਕੇ substantially equivalent determination assumes compliance with the Good Manufacturing Practice for Medical Devices: General (GMP) regulation (21 CFR Part 820) and that, through periodic GMP inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Reqister. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of
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the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.
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 regulation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4692. 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" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".
Sincerely yours,
Timothy A. Unsworth
Timothy A. Ulatowski 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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510(k) Premarket Notification for Biogold Plus Dental Alloy Submitted by european dental imports, inc., Reg#1218814
INDICATIONS FOR USE:
510(K) Number:
Biogold Plus Dental Alloy Device Name:
Indications for Use:
Used by a dental lab technician, under the direction of an attending dentist, to cast elements of fixed and removable dental prostheses:
precious metal bridges, bars, and posts;
precious metal copings, pontics and bridges for porcelain-fused-to-metal restorations.
For porcelain-fused-to-metal restorations it is intended by the manufacturer that only normal-fusing-temperature porcelain products be used with the Biogold Plus alloy.
After fabrication and finishing the completed prosthesis is approved and placed in the patient's mouth by the dentist.
| (Please do not write below this line) | ||
|---|---|---|
| Concurrense of CRRRARSFice of Device Evaluation | ||
| (Division Sign-OffDivision of Dental, Infection Control. | ||
| and General Hospital Devices | ||
| 510(k) Number_________________________________________________________________________________________________________________ | ||
| Prescription User | OR | Over the Counter Use |
| (Per 21 CFR 801.109) |
§ 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.