Duns Number:945015758
Device Description: Universal Abutment UA5 XP 15° - 3.0mm Post
Catalog Number
260-350-735
Brand Name
Universal Abutment
Version/Model Number
260-350-735
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
K092035
Product Code
NHA
Product Code Name
Abutment, Implant, Dental, Endosseous
Public Device Record Key
0aa3e4e8-e784-4901-aaf0-059fc2a91e02
Public Version Date
June 01, 2021
Public Version Number
1
DI Record Publish Date
May 24, 2021
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 | 264 |
2 | A medical device with a moderate to high risk that requires special controls. | 421 |