Bond Apatite

510(k) Number

K121177 ↗

FDA product code

LYC

Device class

Class II

Regulation

21 CFR Part 872.3930

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 LYC (Bone Grafting Material, Synthetic).

• PYROLITE CARBON ALVEOLAR MAINTEN IMPLANT by Carbomedics, Inc.
• Cytrans Granules by Gc America Inc.
• DENTORIDGE(TM) HYDROXYYLAPATITE by Norian Corp.
• BioMend® Extend™ Absorbable Collagen Membrane 0140 by Integra Lifesciences Corp.
• Cytoplast™ Non-Resorbable PTFE Barrier Membranes, Titanium-Reinforced Ti150PTC-2 by OSTEOGENICS BIOMEDICAL, INC.
• Cytoplast™ Non-Resorbable PTFE Barrier Membranes, Titanium-Reinforced Ti250PS-2 by OSTEOGENICS BIOMEDICAL, INC.
• GORE DRAPEABLE ST/LT REGENERATIVE MEMBRANE by W. L. Gore & Associates, Inc.
• IngeniOS ß-TCP Bioactiv Synthetic Bone Particles 1-2mm 1x1cc by curasan AG
• CALFORMA CALCIUM SULFATE BONE GRAFT BARRIER, MODEL 0.5G/1.0G by Lifecore Biomedical, Inc.
• ODONCER by Teknimed, S.A.

• Bond Apatite HA-BB-LMM-NoEU

  Class II

  FDA 510(k) K121177 Active Cleared 5 Dec 2013 GUDID on market

• Bond Apatite HA-BB-LAA-NoEU

  Class II

  FDA 510(k) K121177 Active Cleared 5 Dec 2013 GUDID on market

• Bond Apatite HA-BB-LAM-NoEU

  Class II

  FDA 510(k) K121177 Active Cleared 5 Dec 2013 GUDID on market

• 3D Bond+ 3D-ND-LMM-NoEU

  Class II

  FDA 510(k) K083858 Active Cleared 17 Mar 2009 GUDID on market

See all devices from Augma Biomaterials, Ltd. →