CeraPutty CP10

GUDID 08806387860105

CeraPutty (Bioceramic Root Repair Material) is a ready-to-use, premixed bioceramic root repair material developed for permanent root canal repair and filling applications. It is made of Calcium silicate composite, zirconium dioxide which is a radiopaque agent, and a thickening agent. CeraPutty sets and hardens by the moisture inside the oral cavity. CeraPutty does not shrink during setting and demonstrates excellent physical properties. CeraPutty does not require additional mixing for procedures, and its white color which allows aesthetic treatment. Ceraputty is packaged in a preloaded syringe.

Meta Biomed Co., Ltd.

Hygroscopic dental cement

• Primary Device ID: 08806387860105
• NIH Device Record Key: a7e55a3f-55c9-4ab4-a96f-ee9272f6a4a1
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: CeraPutty CP10
• Version Model Number: 6010
• 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	08806387860105 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K232299

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: 2023-11-23
• Device Publish Date: 2023-11-15

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