Gradia Plus

510(k) Number

K153325 ↗

FDA product code

EBF

FDA applicant

GC America, Inc.

Device class

Class II

Regulation

21 CFR Part 872.3690

Advisory committee

Dental

FDA decision

SESE Substantially Equivalent

Clearances this device's FDA summary refers to, and clearances whose summaries refer to it: a citation, not a claim of equivalence.

Source: 510k-lineage (choiben314), CC BY 4.0

Devices that FDA's GUDID lists as cleared or approved under this submission number. One submission usually covers a whole product family, so the sizes and models are listed here once.

Other devices filed under FDA product code EBF (Material, Tooth Shade, Resin).

• G-CAM GC00033 by GRAPHENANO DENTAL SL.
• Ena Tender ® ETOL by MICERIUM SPA
• HIGH-Q-BOND by Silmet U.S.A. Corp.
• PALFIQUE LITEPOSTERIOR by Tokuyama America, Inc.
• G-CAM GC00265 by GRAPHENANO DENTAL SL.
• OPTIGUARD by Sybron Dental Specialties, Inc.
• Artiste N36AA by KERR CORPORATION
• POST CEMENT HI-X by BISCO INC.
• DENTAL COMPOSITE RESTORATIVE by Dentsply Intl.
• DIAFIL Bulk FLOW (Economic Package);DIAFIL Bulk FLOW (Refill Package);DIAFIL Bulk FLOW (0.5g) by DIADENT GROUP INTERNATIONAL

• G-Bond Universal 10042011

  Class II

  FDA 510(k) K251124 Active Cleared 2 Oct 2025 GUDID on market

• G-Bond Universal 10042010

  Class II

  FDA 510(k) K251124 Active Cleared 2 Oct 2025 GUDID on market

• G-Bond Universal 10042014

  Class II

  FDA 510(k) K251124 Active Cleared 2 Oct 2025 GUDID on market

• G-Bond Universal 10042012

  Class II

  FDA 510(k) K251124 Active Cleared 2 Oct 2025 GUDID on market

See all devices from Gc America Inc. →