Duns Number:094146123
Device Description: 3.5mm Osteotomy Former3.5mm DiameterFor placement of the 4mm ISI/TSI/ERI Maxillary Implant
Catalog Number
0350T
Brand Name
Osteotomy Former
Version/Model Number
3.5mm Osteotomy Former
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
-
Prescription Use (Rx)
-
Over the Counter (OTC)
Yes
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
DZA
Product Code Name
Drill, Dental, Intraoral
Public Device Record Key
8450df8c-2726-4ec2-9b29-e5486982dc76
Public Version Date
January 09, 2020
Public Version Number
4
DI Record Publish Date
April 22, 2016
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 | 76 |
2 | A medical device with a moderate to high risk that requires special controls. | 348 |