Bonemedik-Dm

510(k) Number

K080772 ↗

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).

• OSTEOSCAF by Texas Innovative Medical Devices (Dba) Skeletal
• BIO-INTERFACES 1840 POROUS HA PARTICLES-BII-PORE by Bio-Interfaces, Inc.
• RTR SYRINGE by Septodont
• PERMAMESH-D HYDROXYLAPATITE MATRIX by Ceramed Corp.
• Cytrans™ Elashield by Gc America Inc.
• CMFlexTM by Dimension INX Corp
• Cytoplast™ Non-Resorbable PTFE Barrier Membranes, Titanium-Reinforced Ti250XL-2 by OSTEOGENICS BIOMEDICAL, INC.
• Cytoplast™ PTFE Suture CS071813 by OSTEOGENICS BIOMEDICAL, INC.
• BIO-OSS by Geistlich Pharma AG
• OSSEOGUARD® TR150PN-2 by ZimVie US Corp LLC

• Mx 02-15 0860

  Class I

  GUDID on market

• Mx 02-20 0861

  Class I

  GUDID on market

• Mx 02-40 0865

  Class I

  GUDID on market

• Mx 02-35 0864

  Class I

  GUDID on market

See all devices from Meta Biomed Co., Ltd. →