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.

• 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