Duns Number:078352849
Device Description: Large O ring (Black) for Large ball post Housings that fit Large ball post for two piece i Large O ring (Black) for Large ball post Housings that fit Large ball post for two piece implants
Catalog Number
O Ring Large Black
Brand Name
O - Ring Large Black
Version/Model Number
O Ring Large Black
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
K811923
Product Code
NDP
Product Code Name
Accessories, Implant, Dental, Endosseous
Public Device Record Key
6642dd33-10fc-41fc-a0fc-e12cba18bcbb
Public Version Date
June 21, 2021
Public Version Number
2
DI Record Publish Date
June 01, 2020
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 | 405 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 536 |