Duns Number:436661136
Device Description: ENA-BOND TOTAL ETCH BONDING 3 steps promo kit1 COSM300A2 Ena Bond Light Curing Primer (2 m ENA-BOND TOTAL ETCH BONDING 3 steps promo kit1 COSM300A2 Ena Bond Light Curing Primer (2 ml)1 COSZ10-2 Ena Seal Light Curing Resin (2,5 ml)1 COS101 Ena Etch 37% (2 ml)
Catalog Number
COSM300P
Brand Name
Ena Bond ®
Version/Model Number
COSM300P
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)
-
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
K072978
Product Code
DYH
Product Code Name
Adhesive, Bracket And Tooth Conditioner, Resin
Public Device Record Key
6322257a-0979-4bd6-a9c0-83d03b6b53da
Public Version Date
December 17, 2018
Public Version Number
1
DI Record Publish Date
November 16, 2018
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 | 32 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 231 |