Super Porcelain Stain Pure White

No FDA recalls found in the data synced 22 Oct 2026.

510(k) Number

K983470 ↗

FDA Product Code

EIH

Device Class

Class II

Regulation

21 CFR Part 872.6660

Advisory Committee

Dental

FDA Decision

SESE Substantially Equivalent

• Zirprime

  Class II

  FDA 510(k) K111383 Active Cleared 12 Aug 2011

• Super Porcelain Addmate

  Class II

  FDA 510(k) K983247 Active Cleared 3 Nov 1998

• Paste Opaque Ex-3

  Class II

  FDA 510(k) K982766 Active Cleared 30 Oct 1998

• Katana Zirconia

  Class II

  FDA 510(k) K050160 Active Cleared 7 Feb 2005

• Super Porcelain Ex-3 Press

  Class II

  FDA 510(k) K052304 Active Cleared 23 Nov 2005

• CZR Press LF Stains

  Class II

  FDA 510(k) K050920 Active Cleared 11 May 2005

See all devices from Noritake Co., Inc. →

• What types of dental restorations can this porcelain material be used for, and where is it typically applied in the lab setting?

  This SUPER PORCELAIN STAIN-PURE WHITE is specifically designed for metal framework restorations, meaning it is used in laboratory settings to create porcelain-fused-to-metal (PFM) restorations. It is applied over metallic substructures to fabricate crowns, bridges, and other fixed prosthetics, providing a natural, pure-white aesthetic that matches the patient’s teeth.

• Is this porcelain system intended for single-use, or can it be reused after sterilization?

  The provided data does not explicitly state whether this porcelain system is single-use or reusable. However, since it requires autoclave sterilization or chemical disinfection before clinical use, it implies that the material can be reused after proper sterilization procedures in a laboratory setting. Always follow manufacturer guidelines for reprocessing.

• What regulatory pathway was followed for this dental porcelain, and how does it relate to its intended use?

  This device was cleared through the FDA 510(k) process (K983470), specifically under the Dental (DE) Advisory Committee, with a substantially equivalent (SESE) determination. The clearance was granted for metal framework restorations (product code EIH), meaning it was evaluated as comparable to a legally marketed device for that purpose. The regulatory route confirms its classification as a dental porcelain system for laboratory use in PFM restorations.

• How is this porcelain material supplied, and what considerations should be made when handling it in a dental lab?

  This SUPER PORCELAIN STAIN-PURE WHITE is supplied as part of a dental porcelain system intended for laboratory fabrication of porcelain-fused-to-metal restorations. Since it requires sterilization via autoclave or chemical disinfection before clinical use, labs must ensure proper handling, storage, and reprocessing to maintain sterility and prevent contamination. Always follow the manufacturer’s instructions for preparation and application.