Duns Number:094146123
Device Description: Offset Osteotome Kit (4)All 4 with case1.8mm Offset Osteotome2.65mm Offset Osteotome 3.4mm Offset Osteotome Kit (4)All 4 with case1.8mm Offset Osteotome2.65mm Offset Osteotome 3.4mm Offset Osteotome 4.4mm Offset Osteotome
Catalog Number
OST-OS kit
Brand Name
Offset Osteotome Kit
Version/Model Number
Offset Osteotome Kit (4)
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
DZN
Product Code Name
Instruments, Dental Hand
Public Device Record Key
390cfb75-6d72-43d6-9a8d-afe5cd15985a
Public Version Date
March 29, 2018
Public Version Number
2
DI Record Publish Date
April 29, 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 |