Duns Number:439240722
Device Description: SINGLE USE castable device, titanium threaded sleeve and titanium sphere with nitride coat SINGLE USE castable device, titanium threaded sleeve and titanium sphere with nitride coating to be transformed via casting technique in a metal attachment for removable prosthesis.
Catalog Number
CA012-500
Brand Name
DENTAL EQUIPMENTS
Version/Model Number
S/STEEL HOUSING MICRO size 500 u.
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
July 08, 2021
Issuing Agency
In HIBCC
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
eee560bd-2104-4314-a0cb-47de3fe127e0
Public Version Date
July 09, 2021
Public Version Number
2
DI Record Publish Date
January 05, 2021
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 | 1269 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 1987 |