Cerasorb M Dental

Basic Information

• Brand Name: Cerasorb M Dental
• Primary DI: ECURS10M0150
• Version / Model: 150-500µm
• Catalog Number: 5 x 1.0 cc
• Company Name: curasan AG
• Labeler DUNS: 324331826
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 5
• Record Status: Published
• Publish Date: 2017-02-11
• Public Version: 2
• Public Version Date: 2018-03-29
• Public Version Status: Update
• Public Device Record Key: 23ffd2c2-4070-46d6-8213-607b9383515f

Device Description

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)

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): No
• Over the Counter (OTC): Yes
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: Yes
• Has Expiration Date: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: Yes
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
LYC	Bone Grafting Material, Synthetic	Dental	872.3930	2

GMDN Terms

Code	Name	Definition	Implantable	Status
47971	Dental bone matrix implant, synthetic	A sterile bioabsorbable device made of synthetic material implanted into the body to provide osteoconductive bone-tissue scaffolds to replace maxillofacial and/or mandibular bone lost through trauma or dental surgery. It is typically made of ceramics (e.g., tricalcium phosphate or hydroxyapatite), sometimes bioactive glasses or bioabsorbable polymers, and used to fill bone cavities and defects to promote the ingrowth of endogenous bone for skeletal reconstruction and/or augmentation. It is typically provided as sterile cancellous blocks, chips, or granules of varying sizes, or mouldable materials.	Yes	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	ECURS10M0150	HIBCC
Unit of Use	ECURS10M01505	HIBCC

Customer Contacts

• Phone: [phone]
• Email: [email protected]

Device Sizes

Type	Value	Unit	Text
Total Volume	1.0	Centiliter