G-Cera Porcelain & G-Cera Porcelain Modifier

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

510(k) Number

K880764 ↗

FDA Product Code

ELL

Device Class

Class II

Regulation

21 CFR Part 872.3920

Advisory Committee

Dental

FDA Decision

SESE Substantially Equivalent

• Tuf-Coat

  Class II

  FDA 510(k) K892806 Active Cleared 14 Jul 1989

• Surflex F

  Class II

  FDA 510(k) K844329 Active Cleared 3 Dec 1984

• Limi Alloy

  Class II

  FDA 510(k) K844653 Active Cleared 25 Mar 1985

• Fuji II Lc

  Class II

  FDA 510(k) K913884 Active Cleared 30 Oct 1991

• Cavitron

  Class II

  FDA 510(k) K812568 Active Cleared 25 Sep 1981

• Tooth Shade Resin

  Class II

  FDA 510(k) K895976 Active Cleared 22 Dec 1989

See all devices from G-C Intl. Corp. →

• What is the G-CERA PORCELAIN & G-CERA PORCELAIN MODIFIER used for?

  It is intended for use in dental applications as a restorative material, specifically classified as Teeth, Porcelain under product code ELL, and is used by dental professionals to restore tooth structure in clinical settings.

• Is the G-CERA PORCELAIN & G-CERA PORCELAIN MODIFIER sterile or non-sterile, and is it single-use or reusable?

  The device is supplied as a non-sterile, reusable dental material, meaning it is not provided in a sterile condition and is designed for multiple uses in professional dental settings after appropriate cleaning and preparation by the user.

• What regulatory clearance does the G-CERA PORCELAIN & G-CERA PORCELAIN MODIFIER have?

  It has received FDA 510(k) clearance under submission K880764, is classified as a Class II medical device, and was determined to be substantially equivalent to a legally marketed predicate device.