(56 days)
PlatinLloyd 100 is a crown and bridge type 4 casting alloy. It is a medical device in accordance with Regulation 95712 BBC. Guarder segulaiton requirements are met.
AuroLloyd KF
The provided FDA 510(k) clearance letter and associated documents for the "AuroLloyd® KF" device (K983080) do not contain information about acceptance criteria or a study proving the device meets specific performance metrics.
The documents indicate that the device, "PlatinLloyd 100," is a crown and bridge type 4 casting alloy and is being cleared based on its substantial equivalence to a legally marketed predicate device. The clearance is based on the device meeting CE seal requirements in accordance with Regulation 957/2 BBC (which seems to be a European regulation, potentially 93/42/EEC concerning medical devices or a similar standard, given the context of "Annex IX and CE seal").
Therefore, I cannot provide the requested information as it is not present in the given text. The FDA 510(k) process for substantial equivalence often relies heavily on comparison to an existing predicate device rather than demanding new clinical trials with detailed performance criteria and statistical studies for certain classes of devices, especially materials like dental alloys.
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Image /page/0/Picture/2 description: The image shows the seal of the Department of Health & Human Services USA. The seal is circular and contains the department's name around the perimeter. In the center of the seal is a stylized image of three human profiles facing to the right.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
OCT 28 1998
Mr. William J. Oremus General Manager BEGO U.S.A., Incorporated 1088 Main Street, Suite 200 Pawtucket, Rhode Island 02860
K983080 Re : AuroLloyd® KF Trade Name: Requlatory Class: II Product Code: EJT Dated: August 17, 1998 September 2, 1998 Received:
Dear Mr. Oremus:
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 ase stated in the chorobate, so as 2005 minute 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 The general controls provisions of the Act 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 Regulations, Title 21, Parts 800 to 895. ਚ substantially equivalent determination assumes compliance with the Good Manufacturing Practice for Medical Devices: General (GMP) requlation (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 requlation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in Please note: this response to your the Federal Register. premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.
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Page 2 - Mr. Oremus
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) 594-4692. 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. Ulatowski
Time y A 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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. :
K983080 510(k) Number (if known):
AuroLloyd KF Device Name:
Indications For Use:
PlatinLloyd 100 is a crown and bridge type 4 casting alloy. It is a medical device in PlatinLloyd 100 is a crown and online of the according to Annex IX. The CE seal accordance with Regulation 95712 BBC. Guarder segulaiton requirements are met.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Jse (Per 21 CFR 801.109)
... .
OR
Over-The-Counter Use
(Optional Format 1-2-96)
Suras Riaser
(Division Sign-Off)
Division of Dental, Infection
and General Hospital Devi
510(k) Number Ra83080
§ 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.