(51 days)
PlatinLloyd 100 is : crown and bridge type 4 casting alloy. It is a medical device in PlatinLloyd 100 is ? Crown and online components to Annex IX. The CE seal accordance with Regulation 93/42 EEC. Class IIa according to Annex IX. The CE seal accordance with Regulation 75/42 BEO. Class and were and
Not Found
"1. A table of acceptance criteria and the reported device performance": "The provided document is a 510(k) clearance letter for a medical device (PlatinLloyd 100) and an 'Indications For Use' statement. It does not contain information about acceptance criteria or a study demonstrating device performance. The letter simply states the device is substantially equivalent to legally marketed predicate devices.",
"2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)": "This information is not available in the provided document.",
"3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g., radiologist with 10 years of experience)": "This information is not available in the provided document. The submission is a 510(k) for a casting alloy, not an AI or diagnostic device that typically involves expert ground truth for performance evaluation.",
"4. Adjudication method (e.g., 2+1, 3+1, none) for the test set": "This information is not available in the provided document.",
"5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance": "This information is not available in the provided document. The device is a casting alloy, not an AI-powered diagnostic tool.",
"6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done": "This information is not available in the provided document. The device is a casting alloy, not an AI or algorithmic device.",
"7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)": "This information is not available in the provided document.",
"8. The sample size for the training set": "This information is not available in the provided document. The submission is for a casting alloy, which typically doesn't involve training sets in the AI sense.",
"9. How the ground truth for the training set was established": "This information is not available in the provided document."
}
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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
OCT 2 3 1998
Mr. William J. Oremus General Manager BEGO U.S.A., Incorporated 1088 Main Street, Suite 200 Pawtucket, Rhode Island 02860
K983079 Re : PlatinLloyd 100 Trade Name: Requlatory Class: II Product Code: EJT August 17, 1998 Dated: 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 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 The general controls provisions of the Act of the Act. include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions aqainst 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. A 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 requlation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: 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 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,
Patrux Cuente/foc
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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1 of 1 Page_
K983079 510(k) Number (if known):
PlatinLloyd 100 Device Name:__________________________________________________________________________________________________________________________________________________________________
Indications For Use:
PlatinLloyd 100 is : crown and bridge type 4 casting alloy. It is a medical device in PlatinLloyd 100 is ? Crown and online components to Annex IX. The CE seal
accordance with Regulation 93/42 EEC. Class IIa according to Annex IX. The CE seal accordance with Regulation 75/42 BEO. Class and were and
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
(D
Division
and General
510(k) Number
Prescription 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.