Vita Omega Porcelain

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

510(k) Number

K921474 ↗

FDA Product Code

EIH

Device Class

Class II

Regulation

21 CFR Part 872.6660

Advisory Committee

Dental

FDA Decision

SESE Substantially Equivalent

• Vita Titanium Porcelain

  Class II

  FDA 510(k) K982664 Active Cleared 2 Aug 1998

• Vita Response

  Class II

  FDA 510(k) K000597 Active Cleared 17 May 2000

• V.R.S. Denture Resin Material

  Class II

  FDA 510(k) K962333 Active Cleared 7 Aug 1996

• In-Ceram Spinell

  Class II

  FDA 510(k) K951183 Active Cleared 2 May 1995

• Vita Vm 7, Model NX77 Xxxx, NX78XXXX, NX79 Xxxx; Vita Vm 8, Model VX60 Xxxx, VX61 Xxxx, VX62 Xxxx; Vita Vm 9, Model NX98

  Class II

  FDA 510(k) K060441 Active Cleared 27 Apr 2006

• Vita Pm 7 (20 Gram Bottles), Vita Pm 7 (50 Gram Bottles)

  Class II

  FDA 510(k) K050362 Active Cleared 15 Mar 2005

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• What is Vita Omega Porcelain used for?

  Vita Omega Porcelain is a dental porcelain powder specifically designed for dental restorations and prosthetics, providing both aesthetic and functional results in dental applications.

• How is Vita Omega Porcelain supplied?

  The device is supplied as a porcelain powder intended for dental use, allowing clinicians to create custom restorations and prosthetics with precise material properties.

• What is the regulatory status of Vita Omega Porcelain?

  Vita Omega Porcelain has FDA 510(k) clearance with product code EIH, cleared on June 18, 1992, and is classified under regulation 872.6660, reviewed by the Dental advisory committee.

• Is Vita Omega Porcelain single-use or reusable?

  The device is supplied as a powder material that is used to create dental restorations, which are then placed in the patient's mouth; the porcelain powder itself is not a single-use device but a material for creating final restorations.