Renew-Cera, (BoneMedik-DM 0.3~0.5 mm, 0.50g)

GUDID 08806387896791

Renew-Cera is a coralline hydroxyapatite and a more active tricalcium phosphate bone grafting material for dental and craniofacial usage. It is comprised of 60% silicon substituted hydroxyapatite and 40% [3-tricalcium phosphate.

Meta Biomed Co., Ltd.

Dental bone matrix implant, animal-derived

• Primary Device ID: 08806387896791
• NIH Device Record Key: 3af0d52d-ca86-4fed-94fb-3512da531849
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Renew-Cera, (BoneMedik-DM 0.3~0.5 mm, 0.50g)
• Version Model Number: 9679
• 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	08806387896791 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K080772

FDA Product Code

• LYC: Bone Grafting Material, Synthetic

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2022-09-28
• Device Publish Date: 2022-09-20

Devices Manufactured by Meta Biomed Co., Ltd.

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• 08806387860051 - Jet Flow Bulk A1: 2024-11-25 - Jet Flow Bulk is a low viscosity, visible-light activated, flowable. This low stress flowable material is semi-translucent ena
• 08806387860068 - Jet Flow Bulk A2: 2024-11-25 - Jet Flow Bulk is a low viscosity, visible-light activated, flowable. This low stress flowable material is semi-translucent ena
• 08806387860075 - Jet Flow Bulk A3: 2024-11-25 - Jet Flow Bulk is a low viscosity, visible-light activated, flowable. This low stress flowable material is semi-translucent ena
• 08806387860136 - Jet Flow Bulk Dentin: 2024-11-25 - Jet Flow Bulk is a low viscosity, visible-light activated, flowable. This low stress flowable material is semi-translucent ena
• 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
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• 08806387860112 - CeraPutty CP05: 2023-11-23 CeraPutty (Bioceramic Root Repair Material) is a ready-to-use, premixed bioceramic root repair material developed for permanent