Metapex Plus 0.8

GUDID 08806387894803

This product is a calcium hydroxide paste material that is temporarily filled into the root canal. 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 iodoform contained.Metapex Plus is used for patients of all ages requiring root canal treatment.

Meta Biomed Co., Ltd.

Endodontic filling/sealing material

• Primary Device ID: 08806387894803
• NIH Device Record Key: c172930e-bdbc-4be9-8d70-668fa2ab8a98
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Metapex Plus 0.8
• Version Model Number: 9480
• 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	08806387894803 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K202617

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: 2021-04-26
• Device Publish Date: 2021-04-16

Devices Manufactured by Meta Biomed Co., Ltd.

• 08806387814603 - MX 02-15: 2025-09-03 MGP, 02 Taper 15, 60 Points, P.71
• 08806387814610 - MX 02-20: 2025-09-03 MGP, 02 Taper 20, 60 Points, P.71
• 08806387814627 - MX 02-25: 2025-09-03 MGP, 02 Taper 25, 60 Points, P.71
• 08806387814634 - MX 02-30: 2025-09-03 MGP, 02 Taper 30, 60 Points, P.71
• 08806387814641 - MX 02-35: 2025-09-03 MGP, 02 Taper 35, 60 Points, P.71
• 08806387814658 - MX 02-40: 2025-09-03 MGP, 02 Taper 40, 60 Points, P.71
• 08806387814665 - MX 04-15: 2025-09-03 MGP, 04 Taper 15, 60 Points, P.71
• 08806387814672 - MX 04-20: 2025-09-03 MGP, 04 Taper 20, 60 Points, P.71