Duns Number:324331826
Device Description: Device Name: CERASORB® M DENTALlndications for Use:CERASORB® M DENTAL is recommended for: Device Name: CERASORB® M DENTALlndications 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)
Catalog Number
5 x 2.0 cc
Brand Name
Cerasorb M Dental
Version/Model Number
1000-2000µm
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In HIBCC
MRI safety Status
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)
-
Device labeled as "Not made with natural rubber latex"
-
For Single-Use
Yes
Prescription Use (Rx)
-
Over the Counter (OTC)
Yes
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
LYC
Product Code Name
Bone Grafting Material, Synthetic
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
Package DI Number
None
Quantity per Package
-
Contains DI Package
-
Package Discontinue Date
-
Package Status
-
Package Type
-
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 2 | A medical device with a moderate to high risk that requires special controls. | 58 |