Duns Number:078387192
Device Description: BRANEMARK 4.0 X 2.0MM, LOCATOR ABUTMENT
Catalog Number
08682
Brand Name
LOCATOR
Version/Model Number
08682
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In GS1
MRI safety Status
MR Safe
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
7131ba1a-f2d6-456e-b564-912cc33fec5d
Public Version Date
June 29, 2022
Public Version Number
5
DI Record Publish Date
March 10, 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 | 398 |
2 | A medical device with a moderate to high risk that requires special controls. | 2802 |