Gradia Direct Loflo

510(k) Number

K042348 ↗

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).

• Artiste N36BB by KERR CORPORATION
• FIBERLITE, FIBERLITE HS AND FIBERSEAL by Jeneric/Pentron, Inc.
• CLEARFIL MAJESTY ESTHETIC PLT by Kuraray Medical, Inc.
• OPALUX VISIBLE LIGHT CURED ANTERIOR COMPOSITE by Coe Laboratories, Inc.
• MIRIS2 8433 by Coltène/Whaledent AG
• Simile N56BM by KERR CORPORATION
• CLEARFIL CERAMIC PRIMER by Kuraray Medical, Inc.
• SONICFILL 2010 by Sybron Dental Specialties, Inc.
• Grandio Disc Multicolor by VOCO GmbH
• BRILLIANT NG 8957 NG by Coltène/Whaledent AG

• 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. →