Duns Number:013827410
Device Description: IMPLANT REPLICA, Stainless Steel3.0mm Nobel Active & Replace Conical ConnectionNobel Bioca IMPLANT REPLICA, Stainless Steel3.0mm Nobel Active & Replace Conical ConnectionNobel Biocare Implants
Catalog Number
BA900
Brand Name
DiamoDent
Version/Model Number
N/A
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
7c755ed2-4392-48dc-9842-8d60d56e8f9a
Public Version Date
April 22, 2022
Public Version Number
1
DI Record Publish Date
April 14, 2022
Package DI Number
D907BA9001
Quantity per Package
6
Contains DI Package
D907BA9000
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Pouch
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 78 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 283 |