Duns Number:533432352
Device Description: 3D Bond is a synthetic, osteoconductive, bioresorbable graft binder cement composed of 3D Bond is a synthetic, osteoconductive, bioresorbable graft binder cement composed of biphasic Calcium Sulfate in a granulated powder form. 3D Bond functions as a scaffold for bone regeneration in dental procedures, and is intended to fill, augment or reconstruct bony defects in the oral and maxillofacial region.
Catalog Number
-
Brand Name
3D Bond
Version/Model Number
DD2-100
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In GS1
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)
Yes
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
K083858,K083858
Product Code
LYC
Product Code Name
Bone Grafting Material, Synthetic
Public Device Record Key
658de44a-14b6-4047-89d2-963e68dda722
Public Version Date
July 06, 2018
Public Version Number
3
DI Record Publish Date
September 10, 2015
Package DI Number
17290014838014
Quantity per Package
2
Contains DI Package
07290014838017
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
-
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 2 | A medical device with a moderate to high risk that requires special controls. | 5 |
| U | Unclassified | 1 |