Duns Number:600215680
Device Description: Straight Anatomic Abutment 2mm - PEEK
Catalog Number
-
Brand Name
ANATOMIC ABUTMENT
Version/Model Number
7200011
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
-
Prescription Use (Rx)
-
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
K120530
Product Code
NHA
Product Code Name
Abutment, Implant, Dental, Endosseous
Public Device Record Key
75d12d9f-6211-4e78-9b46-af992cc1bc3c
Public Version Date
November 08, 2019
Public Version Number
2
DI Record Publish Date
March 24, 2019
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 | 98 |
2 | A medical device with a moderate to high risk that requires special controls. | 496 |