Duns Number:113911689
Device Description: Insure Lite Refill Kit (Thin Viscosity) includes 5 (3 g) syringes of Insure Lite (Light-cu Insure Lite Refill Kit (Thin Viscosity) includes 5 (3 g) syringes of Insure Lite (Light-cure resin), 1 Simulcure Catalyst (dual-cure catalyst paste), 2 Cosmedent brushes (#1 and #3), and 25 (16 gauge) tips in the Tray.
Catalog Number
605025
Brand Name
Insure Lite Refill Kit
Version/Model Number
605025
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)
Yes
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
-
Product Code Name
-
Public Device Record Key
99723cf5-e61c-4f6d-9946-6c7294b00afa
Public Version Date
March 29, 2018
Public Version Number
2
DI Record Publish Date
September 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 | 161 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 311 |