Metapaste Plus

GUDID 08806387894766

Metapaste Plus is a water-based calcium hydroxide paste material for root canal temporary filling. It is pre-mixed in a syringe for convenient delivery in the root canal. When applied to root canal, it is alkaline by calcium hydroxide. The state of the treatment can be confirmed by the radiopacity of barium sulfate contained. Also, it is water-soluble and easy to remove.

Meta Biomed Co., Ltd.

Endodontic filling/sealing material

• Primary Device ID: 08806387894766
• NIH Device Record Key: 17453d66-ed7c-4838-a90a-4be88a54f3ab
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Metapaste Plus
• Version Model Number: 9476
• 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	08806387894766 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K210904

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: 2021-07-13
• Device Publish Date: 2021-07-05

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