Duns Number:436664734
Device Description: CROWN PREP TIP TA16D120 -US is a diamond coated tip intended for preparation and finishing CROWN PREP TIP TA16D120 -US is a diamond coated tip intended for preparation and finishing of subgingival margins.
Catalog Number
03590008-101
Brand Name
MECTRON
Version/Model Number
CROWN PREP TIP TA16D120 -US
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
K151248
Product Code
DZI
Product Code Name
Drill, Bone, Powered
Public Device Record Key
de5c85bc-407c-438f-9ff5-c5313aa09f47
Public Version Date
July 06, 2018
Public Version Number
3
DI Record Publish Date
August 30, 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 | 45 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 199 |