Gradia

510(k) Number

K001518 ↗

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).

• SYNERGY D6 8378 by Coltène/Whaledent AG
• OPAKER by Kerr Dental Materials Center
• DenFil DF104-RA11 by VERICOM CO., LTD.
• URENAMEL, POSTERIOR RESTORATIVE MATERIAL by Cadco Dental Products, Inc.
• G-CAM GC00032 by GRAPHENANO DENTAL SL.
• CENTRIX'S ENCORE SOLO LIGHT ACTIVATED RESIN CORE by Alpha-Dent
• CHROMA ZONE COLOR STAIN by Kuraray Medical, Inc.
• ANAXBLEND MODEL 20XXX (SEVERAL), ANAXGUM MODEL 25XXX (U), MOCK-UP DIRECT MODEL 240XXX (U), MOCK-UP DIRECT FLOW MODEL 24A by Anaxdent GmbH
• PULPDENT DENTAL BOND ENCHANCER by Pulpdent Corporation
• LC MICROFILL by S & C Polymer GmbH

• 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. →