Duns Number:318268125
Device Description: STOMA® micro-screws Ø1,2 X 4mm are developed and manufactured to be used as non-active bo STOMA® micro-screws Ø1,2 X 4mm are developed and manufactured to be used as non-active bone surgery implants for the treatment of bone fractures in the dental field. They are recommended especially for the fixation of transplanted bone blocks and small grafts during the augmentation process in the oral cavity and maxillomandibular surgical field, e.g. for horizontal, vertical or 3D augmentative grafts. The small-sized diameter of the screw head enables various applications. STOMA® micro-screws are delivered in non-sterile conditions.
Catalog Number
23061.04
Brand Name
STOMA® micro-screw
Version/Model Number
23061.04
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
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
K080430,K080430
Product Code
DZL
Product Code Name
Screw, Fixation, Intraosseous
Public Device Record Key
df9e3e54-a372-4005-9447-0ad951bb2b7f
Public Version Date
July 06, 2018
Public Version Number
3
DI Record Publish Date
October 17, 2015
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 | 1204 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 2 |