Duns Number:825137818
Device Description: COMPOLITE UNIVERS BOND 8th Generation 7ML
Catalog Number
5253728
Brand Name
Darby Dental Supply, LLC
Version/Model Number
5253728
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)
Yes
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
KLE
Product Code Name
AGENT, TOOTH BONDING, RESIN
Public Device Record Key
77f3e1b2-74a6-4eba-9545-d793f60b7e75
Public Version Date
March 01, 2022
Public Version Number
1
DI Record Publish Date
February 21, 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 |
---|---|---|
1 | A medical device with low to moderate risk that requires general controls | 1457 |
2 | A medical device with a moderate to high risk that requires special controls. | 194 |
U | Unclassified | 2 |