Duns Number:124763728
Device Description: The SternSnap Attachment is indicated for use with dental implants to support and/or retai The SternSnap Attachment is indicated for use with dental implants to support and/or retain removable dental prostheses in the treatment of partially or totally edentulous patients to restore chewing function. The attachment screws into SFI Abutments which are screwed into endosseous implants. The SternSnap Attachment consists of a modified ball, which screws into an SFI Abutment and a retaining cap that gets processed into the denture. The retaining female engages the outside of the ball shape and allows retention of the prosthesis to the denture.
Catalog Number
-
Brand Name
Stern Snap One Piece Abutment 1mm Cuff (AP)
Version/Model Number
904572
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
537dd841-66fd-409d-854d-bb0fcd941b4d
Public Version Date
January 08, 2020
Public Version Number
6
DI Record Publish Date
May 18, 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 |