CeraSeal

GUDID 08806387894124

CeraSeal is used for root canal filling after the removal of infected pulp tissue in the root canal. CeraSeal is in the form of a flowable paste and can be immediately applied inside the root canal using a disposable tip. material, and a thickening agent. This product characteristically cures slowly by absorbing the ambient water inside the root canal. It is white and aesthetic.

Meta Biomed Co., Ltd.

Endodontic filling/sealing material

• Primary Device ID: 08806387894124
• NIH Device Record Key: e7ce3503-d02c-4c46-9b93-0b9e75edad41
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: CeraSeal
• Version Model Number: 9412
• 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: false
• 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: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	08806387894124 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K190503

FDA Product Code

• KIF: Resin, Root Canal Filling

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2019-07-02
• Device Publish Date: 2019-06-24

Devices Manufactured by Meta Biomed Co., Ltd.

• 08806387860044 - Jet Flow Bulk Universal: 2024-11-25 - Jet Flow Bulk is a low viscosity, visible-light activated, flowable. This low stress flowable material is semi-translucent ena
• 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
• 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