Duns Number:067488114
Device Description: IMPULSE is a hand held and operated crown remover. It is a spring loaded device with 3 pow IMPULSE is a hand held and operated crown remover. It is a spring loaded device with 3 power settings. Two different tips are provided: A chisel tip for removing cemented crowns off a tooth or implant abutment, A pointed tip for removing cemented bridges, splints, and crowns. The IMPULSE provides a shock "Pulse" to the restoration to break the seal of the cement and allows the restoration to be removed with certain cements.
Catalog Number
99-1035
Brand Name
TAUB - Trident - IMPULSE
Version/Model Number
Crown & Bridge Remover - Polished
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"
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For Single-Use
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Prescription Use (Rx)
-
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
EIS
Product Code Name
Remover, Crown
Public Device Record Key
b26857c3-48ad-4d12-9992-b51009f1de2d
Public Version Date
June 17, 2022
Public Version Number
2
DI Record Publish Date
February 25, 2020
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 | 28 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 130 |