Duns Number:318034329
Device Description: BL RC Burn-out plastic coping for crown, Ø 6.5 mm for OCTAGON Infinity Dental Implant BL R BL RC Burn-out plastic coping for crown, Ø 6.5 mm for OCTAGON Infinity Dental Implant BL RC
Catalog Number
5022119
Brand Name
OCTAGON Infinity BL RC Burn-out plastic coping for crown, Ø 6.5 mm
Version/Model Number
5022119
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
December 06, 2016
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
c516244c-56a3-4c5e-8ebe-48b81aaa41c8
Public Version Date
November 08, 2019
Public Version Number
4
DI Record Publish Date
September 08, 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 | 4140 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 237 |