AccessGUDID - DEVICE: Cerasorb M Dental (ECURS20M1000)

GUDID

Device Identifier (DI) Information

Brand Name: Cerasorb M Dental
Version or Model: 1000-2000µm
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 5 x 2.0 cc
Company Name: curasan AG

Primary DI Number: ECURS20M1000
Issuing Agency: HIBCC
Commercial Distribution End Date:
Device Count: 5
Labeler D-U-N-S® Number*: 324331826 *Terms of Use

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

What MRI safety information does the labeling contain?	Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437):	No
Device labeled as "Not made with natural rubber latex":	No
For Single-Use:	Yes
Prescription Use (Rx):	No
Over the Counter (OTC):	Yes
Kit:	No
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
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.	Active	true

FDA Product Code

[?]

Product Code	Product Code Name
LYC	Bone Grafting Material, Synthetic

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
Premarket Submission Number Not Available/Not Released

Device Exempt from Premarket Submission: No CLOSE

Sterilization

Device Packaged as Sterile: Yes
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
Total Volume: 2.0 Centiliter

Device Record Status

Public Device Record Key: 4d2c132b-ea93-485d-bd7c-c83c6fecd417
Public Version Date: March 29, 2018
Public Version Number: 2
DI Record Publish Date: February 11, 2017