(71 days)
For use in prosthetic dentistry to create the porcelain exterior on a porcelain fused to metal (PFM) dental prosthesis.
Not Found
The provided text describes a 510(k) premarket notification for a dental device, "Super Porcelain EX-3 Universal Opaque." It is a regulatory document from the FDA, not a study report. Therefore, it does not contain the information requested in the prompt regarding acceptance criteria, device performance, or study details.
The document primarily focuses on:
- Device Name: Super Porcelain EX-3 Universal Opaque
- Regulation Number: 21 CFR 872.6660
- Regulation Name: Porcelain Powder for Clinical Use
- Regulatory Class: II
- Product Code: EIH
- Indications for Use: "For use in prosthetic dentistry to create the porcelain exterior on a porcelain fused to metal (PFM) dental prosthesis."
- Substantial Equivalence: The FDA determined the device is substantially equivalent to legally marketed predicate devices.
None of the requested information regarding acceptance criteria, study design, sample sizes, ground truth establishment, or expert qualifications is present in this regulatory correspondence.
§ 872.6660 Porcelain powder for clinical use.
(a)
Identification. Porcelain powder for clinical use is a device consisting of a mixture of kaolin, felspar, quartz, or other substances intended for use in the production of artificial teeth in fixed or removable dentures, of jacket crowns, facings, and veneers. The device is used in prosthetic dentistry by heating the powder mixture to a high temperature in an oven to produce a hard prosthesis with a glass-like finish.(b)
Classification. Class II.