Duns Number:124763728
Device Description: Rigid attachments are highly stable connectors with very slight movements in function. Wh Rigid attachments are highly stable connectors with very slight movements in function. When abutment teeth are stable, rigid attachments are often the connectors of choice. Some can be used for segmenting fixed partial dentures to simplify future case conversion to a removable restoration.
Catalog Number
-
Brand Name
Stern Latch® Male
Version/Model Number
802012
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
January 20, 2021
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
-
Product Code
EGG
Product Code Name
Attachment, Precision, All
Public Device Record Key
0883c97a-49d4-4722-9036-8e08463c6983
Public Version Date
January 21, 2021
Public Version Number
2
DI Record Publish Date
July 02, 2020
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 |