BoneMedik, 0.5~1mm, 10cc

GUDID 08806387895091

BoneMedik is coralline hydroxyapatite bone void fillers. BoneMedik is osteoconductive porous implant materials similar in structure to human cancellous bone. The material is trabecular hydroxyapatite.

Meta Biomed Co., Ltd.

Bone matrix implant, synthetic, non-antimicrobial

• Primary Device ID: 08806387895091
• NIH Device Record Key: 26ed72ac-631d-49c1-ae40-05a6de620332
• Commercial Distribution Discontinuation: 2019-03-31
• Commercial Distribution Status: Not in Commercial Distribution
• Brand Name: BoneMedik, 0.5~1mm, 10cc
• Version Model Number: 9509
• Company DUNS: 688322841
• Company Name: Meta Biomed Co., Ltd.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: true
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	08806387895091 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K070897

FDA Product Code

• MQV: Filler, Bone Void, Calcium Compound

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: true

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 5
• Public Version Date: 2022-01-24
• Device Publish Date: 2016-09-19

Devices Manufactured by Meta Biomed Co., Ltd.

• 08806387860129 - EZ Bond Universal (EZB50): 2024-06-13 EZ Bond Universal is dentin adhesion system that functions as a conditioner, primer and adhesive resin in a single component. EZ
• 08806387860105 - CeraPutty CP10: 2023-11-23 CeraPutty (Bioceramic Root Repair Material) is a ready-to-use, premixed bioceramic root repair material developed for permanent
• 08806387860112 - CeraPutty CP05: 2023-11-23 CeraPutty (Bioceramic Root Repair Material) is a ready-to-use, premixed bioceramic root repair material developed for permanent
• 08806387894780 - ADSEAL Plus Auto-Mix: 2023-06-19 ADSEAL Plus root canal sealer is a two component paste:paste device based upon epoxy-amine resin chemistry. This sealer is easy
• 08806387894773 - ADSEAL Plus: 2023-05-02 ADSEAL Plus root canal sealer is a two component paste:paste device based upon epoxy-amine resin chemistry. This sealer is easy
• 08806387860082 - EZ Bond Universal 5.0 (EZB50): 2023-04-20 EZ Bond Universal is dentin adhesion system that functions as a conditioner, primer and adhesive resin in a single component.
• 08806387892069 - ADSEAL: 2023-04-19 Adseal root canal sealer is a two component paste:paste device based upon epoxy-amine resin chemistry. This sealer is easy to mi
• 08806387892007 - Metapex(1 Syringe): 2023-04-13 Metapex is a paste type root canal filling material. It is consist of Calcium Hydroxide with lodoform. 1 Syringe(2.2g)