Duns Number:083235549
Device Description: Curing Probe, 2mm - 90° angle tapered
Catalog Number
644717
Brand Name
Fiber Optic Probe For use with DENTSPLY Curing lights
Version/Model Number
644717
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
November 05, 2019
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)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
EBZ
Product Code Name
ACTIVATOR, ULTRAVIOLET, FOR POLYMERIZATION
Public Device Record Key
7c7cd8fc-06be-4912-a9f0-23bf87d6cd85
Public Version Date
October 03, 2022
Public Version Number
3
DI Record Publish Date
September 21, 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 | 123 |
2 | A medical device with a moderate to high risk that requires special controls. | 397 |
U | Unclassified | 2 |