Duns Number:316699578
Device Description: Set blocks 2 × No. 12 (A2 LT, A3 HT), 3 × No. 14L (A3 LT, A3 HT, A3.5 LT), Bifix QM QuickM Set blocks 2 × No. 12 (A2 LT, A3 HT), 3 × No. 14L (A3 LT, A3 HT, A3.5 LT), Bifix QM QuickMix syringe 10 g universal, Futurabond U SingleDose 5 pcs., Ceramic Bond bottle 5 ml, Dimanto set, accessories
Catalog Number
6000
Brand Name
Grandio blocs
Version/Model Number
6000
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
43d9e1c1-fc71-40d2-a475-92905cea87c5
Public Version Date
October 29, 2021
Public Version Number
3
DI Record Publish Date
August 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 |