IPS EMPRESS 2

• K Number: K982616
• Device Name: IPS EMPRESS 2
• Manufacturer: IVOCLAR NORTH AMERICA, INC.
• Date Cleared: 1998-09-08 ( 43 days)
• Product Code: EIH
• Regulation Number: 872.6660
• Type: Traditional
• Panel: DE
• Reference & Predicate Devices: N/A

Intended Use

Metal free single unit and anterior multiple unit Bonded Crown and Bridge Restoration

Device Description

Not Found

AI/ML Overview

The provided document is a 510(k) clearance letter from the FDA for a dental restoration device, IPS Empress 2. It states that the device is substantially equivalent to legally marketed predicate devices.

However, the document does not contain any information regarding acceptance criteria, device performance studies, sample sizes, expert qualifications, ground truth establishment, or any of the other specific details requested in your prompt. This type of information would typically be found in a more detailed submission summary, clinical study reports, or performance testing documentation, which are not part of this clearance letter.

Therefore, I cannot fulfill your request with the provided input. The document merely confirms the FDA's decision to allow the device to be marketed.

Regulation Number and Section

§ 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.