Duns Number:600215680
Device Description: Rapid dental implant D=3.8mm, L=8mm
Catalog Number
-
Brand Name
DENTIN RAPID IMPLANTS
Version/Model Number
DCL-0838
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)
-
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
K120530,K120530
Product Code
DZE
Product Code Name
Implant, Endosseous, Root-Form
Public Device Record Key
2b5eccaf-0d2e-4aef-934b-ee2526603e82
Public Version Date
October 11, 2018
Public Version Number
1
DI Record Publish Date
September 10, 2018
Package DI Number
07290113351059
Quantity per Package
10
Contains DI Package
07290113350052
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
-
Device Class | Device Class Description | No of Devices |
---|---|---|
1 | A medical device with low to moderate risk that requires general controls | 98 |
2 | A medical device with a moderate to high risk that requires special controls. | 496 |