Duns Number:094146123
Device Description: 5mm Crown & Bridge Abutment5mm Diameter2mm CollarFor multiple unit restorations only (not 5mm Crown & Bridge Abutment5mm Diameter2mm CollarFor multiple unit restorations only (not for single tooth restoration)
Catalog Number
5045-2CB
Brand Name
Bone Level Implant Abutment
Version/Model Number
5mm Crown & Bridge Abutment
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)
Yes
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
NHA
Product Code Name
Abutment, Implant, Dental, Endosseous
Public Device Record Key
cba5968e-a6aa-4cad-9cf3-de82f1aefa66
Public Version Date
March 29, 2018
Public Version Number
2
DI Record Publish Date
April 11, 2016
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 |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 76 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 348 |