Duns Number:124763728
Device Description: SternSnap Overdenture Implant Abutment System that can be used to retain overdentures on m SternSnap Overdenture Implant Abutment System that can be used to retain overdentures on most popular implants. It features a low profile that takes up only 2.5mm of height in the denture and has a long-lasting plastic retention cap that comes in three retention levels (1 lb, 2lb and 3 lb) and doesn’t require a metal housing, making it a simpler, more economical option. Contents: 1 attachment, 1 each Yellow and Green retaining caps, 1 blockout spacer.
Catalog Number
-
Brand Name
Stern Snap One Piece Abutment 3mm Cuff (AE)
Version/Model Number
904808
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
K142407
Product Code
NHA
Product Code Name
Abutment, Implant, Dental, Endosseous
Public Device Record Key
4c6386a6-8ccd-47bd-9b06-27f5cdd42efd
Public Version Date
January 10, 2020
Public Version Number
6
DI Record Publish Date
May 23, 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 |