Duns Number:789664455
Device Description: Orion is a light-cure core build-up material. It has, virtually, unlimited working time. M Orion is a light-cure core build-up material. It has, virtually, unlimited working time. Material is easy to carve and contour, due to it, moderately hard filler. It is moldable, non-sticky yet adhesive consistency. Material has long shelf life at ambient temperatures and its X-ray opaque.
Catalog Number
1019
Brand Name
Orion Light Cured Core Build-Up Material
Version/Model Number
1019
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"
Yes
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
-
Product Code
EBF
Product Code Name
Material, Tooth Shade, Resin
Public Device Record Key
ec5d8dfa-7746-4b2c-9f86-87638d41b09a
Public Version Date
March 29, 2018
Public Version Number
2
DI Record Publish Date
September 03, 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 | 3 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 59 |