Duns Number:480420090
Device Description: Core build up - 6 posts + 1 reamer RA of each #1-4 - N°1Total Length 19mmLength of tapered Core build up - 6 posts + 1 reamer RA of each #1-4 - N°1Total Length 19mmLength of tapered part 11mmDiameter of the lower tip 0.85mmDiameter of the cylindrical part 1.30mmN°2Total Length 19mmLength of tapered part 11mmDiameter of the lower tip 1.06mmDiameter of the cylindrical part 1.50mmN°3Total Length 19mmLength of tapered part 11mmDiameter of the lower tip 1.26mmDiameter of the cylindrical part 1.70mmN°4Total Length 19mmLength of tapered part 11mmDiameter of the lower tip 1.47mmDiameter of the cylindrical part 1.90mm
Catalog Number
-
Brand Name
FIBRAPOST PLUS N°1-4 (24 glass fibre posts + 4 reamers + 1 screwdiver)
Version/Model Number
22595
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In GS1
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
ELR
Product Code Name
Post, Root Canal
Public Device Record Key
68bfa57a-2cb1-4fe7-a8ab-eb1af24a7843
Public Version Date
June 30, 2022
Public Version Number
1
DI Record Publish Date
June 22, 2022
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 | 278 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 1 |