Duns Number:835556429
Device Description: 3.5mm O-Ring System Kit 3mm Abutment (kit includes abutment, 3 red o-rings, 3 white o-ring 3.5mm O-Ring System Kit 3mm Abutment (kit includes abutment, 3 red o-rings, 3 white o-rings, o-ring keeper & analog)
Catalog Number
ORS3503
Brand Name
American Dental Implant
Version/Model Number
ORS3503
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
K080397
Product Code
NHA
Product Code Name
Abutment, Implant, Dental, Endosseous
Public Device Record Key
1ef7d3d4-ddcc-4909-b9f3-b14afef0d5d6
Public Version Date
November 08, 2019
Public Version Number
2
DI Record Publish Date
July 31, 2018
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 | 43 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 190 |