Duns Number:480619001
Device Description: saremco print CROWNTEC is a light-curing, flowable polymer based on methacrylic acid ester saremco print CROWNTEC is a light-curing, flowable polymer based on methacrylic acid ester for production of 3D-printed permanent crowns, inlays, onlays, veneers, temporary crowns & bridges, and artificial teeth (i.e., complete or partial dentures).
Catalog Number
8065
Brand Name
Crowntec
Version/Model Number
B1
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
K213343
Product Code
EBF
Product Code Name
Material, Tooth Shade, Resin
Public Device Record Key
c47639a3-c1b9-4a15-be9c-cbe6526a0fc4
Public Version Date
March 23, 2022
Public Version Number
1
DI Record Publish Date
March 15, 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 |
|---|---|---|
| 2 | A medical device with a moderate to high risk that requires special controls. | 5 |