Cerasorb M Dental 5 x 1.0 cc

GUDID ECURS10M0500

Device Name: CERASORB® M DENTAL lndications for Use: CERASORB® M DENTAL is recommended for: - Augmentation or reconstructive treatment of the alveolar ridge - Filling of infrabony periodontal defects - Filling of defects after root resection, apicoectomy and cystectomy - Filling of extraction sockets to enhance preservation of the alveolar ridge - Elevation of the maxillary sinus floor - Filling of periodontal defects in conjunction with products intended for Guided Tissue Regeneration (GTR) and Guided Bone Regeneration (GBR) - Filling of peri-implant defects in conjunction with products intended for Guided Bone Regeneration (GBR)

curasan AG

Dental bone matrix implant, synthetic

• Primary Device ID: ECURS10M0500
• NIH Device Record Key: 92616f18-ae12-4a68-9116-398c22fb11de
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Cerasorb M Dental
• Version Model Number: 500-1000µm
• Catalog Number: 5 x 1.0 cc
• Company DUNS: 324331826
• Company Name: curasan AG
• Device Count: 5
• 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: true
• 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: false
• OTC Over-The-Counter: true

Customer Support Contacts

• Phone: +496027409000
• Email: info@curasan.de

Device Dimensions

• Total Volume: 1 Centiliter

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	ECURS10M0500 [Primary]
HIBCC	ECURS10M05005 [Unit of Use]

FDA Product Code

• LYC: Bone Grafting Material, Synthetic

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2018-03-29
• Device Publish Date: 2017-02-11

On-Brand Devices [Cerasorb M Dental]

• ECURS20M1000: Device Name: CERASORB® M DENTAL lndications for Use: CERASORB® M DENTAL is recommended for: -
• ECURS20M0500: Device Name: CERASORB® M DENTAL lndications for Use: CERASORB® M DENTAL is recommended for: -
• ECURS20M0150: Device Name: CERASORB® M DENTAL lndications for Use: CERASORB® M DENTAL is recommended for: -
• ECURS10V0500: Device Name: CERASORB® M DENTAL lndications for Use: CERASORB® M DENTAL is recommended for: -
• ECURS10M1000: Device Name: CERASORB® M DENTAL lndications for Use: CERASORB® M DENTAL is recommended for: -
• ECURS10M0500: Device Name: CERASORB® M DENTAL lndications for Use: CERASORB® M DENTAL is recommended for: -
• ECURS10M0150: Device Name: CERASORB® M DENTAL lndications for Use: CERASORB® M DENTAL is recommended for: -
• ECURS05V0500: Device Name: CERASORB® M DENTAL lndications for Use: CERASORB® M DENTAL is recommended for: -
• ECURS05M1000: Device Name: CERASORB® M DENTAL lndications for Use: CERASORB® M DENTAL is recommended for: -
• ECURS05M0500: Device Name: CERASORB® M DENTAL lndications for Use: CERASORB® M DENTAL is recommended for: -
• ECURS05M0150: Device Name: CERASORB® M DENTAL lndications for Use: CERASORB® M DENTAL is recommended for: -