Duns Number:106744280
Device Description: IBT Resin is a light-curable polymer based material designed for 3D printing biocompatible IBT Resin is a light-curable polymer based material designed for 3D printing biocompatible, indirect bonding trays for dental bracket placement. Users should independently verify the suitability of the printed materials for their particular application and intended purpose. IBT Resin is a photopolymer resin made of a mixture of methacrylic esters and photoinitiators.
Catalog Number
-
Brand Name
IBT Resin
Version/Model Number
FLIBCL01
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)
-
Over the Counter (OTC)
Yes
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
23e076d0-5b99-4013-bf4a-45bab07bd6cd
Public Version Date
November 10, 2021
Public Version Number
2
DI Record Publish Date
February 16, 2021
Package DI Number
10860002099344
Quantity per Package
8
Contains DI Package
00860002099347
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Case
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 3 |