Duns Number:316699578
Device Description: set, 5 posts each (~ ø 0,8 mm, ~ ø 1,0 mm, ~ ø 1,2 mm, ~ ø 1,4 mm), Ceramic Bond, Bottle, set, 5 posts each (~ ø 0,8 mm, ~ ø 1,0 mm, ~ ø 1,2 mm, ~ ø 1,4 mm), Ceramic Bond, Bottle, 5 ml, Futurabond U Single Dose (20 pcs.), Rebilda DC QuickMix syringe 10 g dentine
Catalog Number
-
Brand Name
Rebilda Post GT
Version/Model Number
1972
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
EBF
Product Code Name
Material, Tooth Shade, Resin
Public Device Record Key
ac0d25a3-abae-4607-b882-e827855a5615
Public Version Date
March 29, 2018
Public Version Number
2
DI Record Publish Date
November 24, 2017
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 |