Duns Number:124763728
Device Description: PUR UCLA Abutment RP Engaging - Gold. The UCLA-Type Abutment is attached directly to the PUR UCLA Abutment RP Engaging - Gold. The UCLA-Type Abutment is attached directly to the implant. It provides a pattern for the creation of a screw retained veneered crown. UCLA-Type Abutments are available in single-implant (hexed) and multi-implant (non-hexed) designs. This abutment is well suited for sites with minimal thickness of soft tissue.
Catalog Number
-
Brand Name
PUR UCLA Abutment RP Engaging - GOLD
Version/Model Number
904766
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
K151928
Product Code
NHA
Product Code Name
Abutment, Implant, Dental, Endosseous
Public Device Record Key
1d82ce0a-dd81-4067-a701-cbfe0ffc9213
Public Version Date
January 07, 2020
Public Version Number
6
DI Record Publish Date
March 06, 2017
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 | 16 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 1346 |