Duns Number:809646136
Device Description: DiamondCrown-DCBLOK(CADCAM)-I-10mm A1/B1 - DRM-Laminate/Veneer/Inlay/Onlay/Crown-CADCAM-BL DiamondCrown-DCBLOK(CADCAM)-I-10mm A1/B1 - DRM-Laminate/Veneer/Inlay/Onlay/Crown-CADCAM-BLOK-PolyCeramRestorative Materials, Dental Crown & Bridge, Accessories, Implant Dental - Endosseous, ZTi-DiamondCrown-Integrated-Implant-Superstructure System, Permanent, Preformed
Catalog Number
DCBK701
Brand Name
DiamondCrown-DCBLOK
Version/Model Number
DCBLOK-I-10mm A1/B1
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
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
NDP
Product Code Name
Accessories, Implant, Dental, Endosseous
Public Device Record Key
1f299ed1-4791-44dc-b451-7b8d87915513
Public Version Date
June 30, 2020
Public Version Number
1
DI Record Publish Date
June 22, 2020
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 | 10 |