Finesse Low-Fusing Porcelain System Auxiliary Products

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

510(k) Number

K961291 ↗

FDA Product Code

EIH

Device Class

Class II

Regulation

21 CFR Part 872.6660

Advisory Committee

Dental

FDA Decision

SESE Substantially Equivalent

• Disposable Screw Type Prophy Brush

  Class I

  FDA 510(k) K900507 Active Cleared 10 Apr 1990

• Sterile Flexofile Files and Instruments

  Class I

  FDA 510(k) K971606 Active Cleared 3 Jun 1997

• Delton F Pit & Fissure Sealant

  Class II

  FDA 510(k) K951296 Active Cleared 3 May 1995

• Fluoride Varnish

  Class II

  FDA 510(k) K031932 Active Cleared 15 Sep 2003

• Dentsply Cavitron Sps Scaler System

  Class II

  FDA 510(k) K970123 Active Cleared 11 Apr 1997

• Delton Fs Direct Delivery System

  Class II

  FDA 510(k) K982564 Active Cleared 6 Oct 1998

See all devices from Dentsply Intl. →

• What are the Finesse Low-Fusing Porcelain System Auxiliary Products used for?

  These auxiliary products are used by dental technicians in laboratory settings to create varied fusion temperatures, translucencies, and colors for dental prostheses when applied with the Finesse Low-Fusing Porcelain System. They include mixtures of frits, opacifiers, and pigments such as opaque modifiers, opaque correction, dentin correction, stains, and glaze porcelains.

• What components are included in the Finesse Low-Fusing Porcelain System Auxiliary Products?

  The auxiliary products include opaque modifiers, opaque correction, dentin correction, stains, and glaze porcelains. These are mixtures of frits, opacifiers, and pigments designed to work with the Finesse Low-Fusing Porcelain System to achieve desired aesthetic and functional properties in dental restorations.

• How were the Finesse Low-Fusing Porcelain System Auxiliary Products cleared for market?

  The product was cleared by the FDA under 510(k) K961291 on May 28, 1996, as substantially equivalent to a legally marketed device. It is classified as Powder, Porcelain (product code EIH), Class II with Special Controls, based on a traditional 510(k) submission reviewed by the Dental advisory committee.