Duns Number:318034329
Device Description: BL NC Burn-out plastic coping for bridge/bar, Ø 3.5 mm for OCTAGON Infinity Dental Implant BL NC Burn-out plastic coping for bridge/bar, Ø 3.5 mm for OCTAGON Infinity Dental Implant BL NC
Catalog Number
5022035
Brand Name
OCTAGON Infinity BL NC Burn-out plastic coping for bridge/bar, Ø 3.5 mm
Version/Model Number
5022035
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
fbcce0da-79a1-45ab-976a-0a7cd2b5cd45
Public Version Date
November 08, 2019
Public Version Number
5
DI Record Publish Date
September 09, 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 |