(51 days)
Not Found
Not Found
No
The provided 510(k) summary describes a casting alloy and contains no mention of AI, ML, or related technologies.
No
The text indicates it's a "crown and bridge type 4 casting alloy," which is a material used in dentistry, not a therapeutic device for direct treatment or therapy. Its classification as "Class IIa according to Annex IX" further clarifies it as a medical device, but not specifically a therapeutic one in the context of providing therapy.
No
The intended use describes the device as a "crown and bridge type 4 casting alloy," which is a material for dental restorations, not a diagnostic tool.
No
The provided 510(k) summary describes a "crown and bridge type 4 casting alloy," which is a physical material used in dentistry, not a software-only device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states "crown and bridge type 4 casting alloy." This describes a material used in dental restorations, which is a physical device implanted or used in the body, not a device used to examine specimens derived from the human body for diagnostic purposes.
- Lack of IVD Indicators: The description does not mention any of the typical characteristics of an IVD, such as analyzing biological samples (blood, urine, tissue), detecting biomarkers, or providing diagnostic information about a patient's health status.
Therefore, based on the provided text, PlatinLloyd 100 is a dental casting alloy and not an In Vitro Diagnostic device.
N/A
{
"Intended Use / 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\naccordance with Regulation 93/42 EEC. Class IIa according to Annex IX. The CE seal accordance with Regulation 75/42 BEO. Class and were and",
"Product codes": "EJT",
"Device Description": "Not Found",
"Mentions image processing": "Not Found",
"Mentions AI, DNN, or ML": "Not Found",
"Input Imaging Modality": "Not Found",
"Anatomical Site": "Not Found",
"Indicated Patient Age Range": "Not Found",
"Intended User / Care Setting": "Not Found",
"Description of the training set, sample size, data source, and annotation protocol": "Not Found",
"Description of the test set, sample size, data source, and annotation protocol": "Not Found",
"Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)": "Not Found",
"Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)": "Not Found",
"Predicate Device(s)": "Not Found",
"Reference Device(s)": "Not Found",
"Predetermined Change Control Plan (PCCP) - All Relevant Information": "Not Found"
}
§ 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.
0
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.
1
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
2
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)
{