Duns Number:340306351
Device Description: inCoris Intro-Kit Nconsists of 1 pcs of:6135458 BLOCK 40/15 ZI F2 6135854 BLOCK 40/19 ZI inCoris Intro-Kit Nconsists of 1 pcs of:6135458 BLOCK 40/15 ZI F2 6135854 BLOCK 40/19 ZI F2 6122753 BLOCK 40/19 ZI F0.56339456 Block inCoris TZI 40/196605773 CEREC Blocs C In BL26449990 CEREC Blocs C In A16605781 CEREC Blocs C In A26605799 CEREC Blocs C In A36605807 CEREC Blocs C In A3,56605815 CEREC Blocs C In A46480433 Block inCoris TZI C mono L 20/19 A16480441 Block inCoris TZI C mono L 20/19 A26480458 Block inCoris TZI C mono L 20/19 A36480466 Block inCoris TZI C mono L 20/19 A3,56480474 Block inCoris TZI C mono L 20/19 A4
Catalog Number
-
Brand Name
inCoris & CEREC
Version/Model Number
6535756
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
Yes
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
EIH
Product Code Name
Powder, Porcelain
Public Device Record Key
0885902d-cb7c-46e0-ada4-11ea6940c427
Public Version Date
May 17, 2022
Public Version Number
4
DI Record Publish Date
September 16, 2016
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 | 235 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 326 |