Duns Number:316699578
Device Description: lndivido Lux blue opaque and lndivido Lux transparent blue are opaquerespectively transpar lndivido Lux blue opaque and lndivido Lux transparent blue are opaquerespectively transparent light-curing resins in form of contoured plates formaxillae and mandibles for the fabrication of individual trays for use in crown,bridge and total prosthetic technique as well as for the fabrication of basesfor bite patterns and odontograms. They are ready for use and easy to handlewithout any odor nuisance.
Catalog Number
2201
Brand Name
Individo Lux
Version/Model Number
2201
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
EBH
Product Code Name
Material, Impression Tray, Resin
Public Device Record Key
41f2cd00-0b23-44d8-8ae1-47c219491afb
Public Version Date
June 14, 2019
Public Version Number
1
DI Record Publish Date
June 06, 2019
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 | 40 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 396 |
| U | Unclassified | 5 |