Duns Number:316699578
Device Description: Solobond Plus is a light-curing two-stage universal bonding agent that produces apermanent Solobond Plus is a light-curing two-stage universal bonding agent that produces apermanent bonding without marginal leakage between hard tooth substance (dentin/enamel) and composite.
Catalog Number
1044
Brand Name
Solobond Plus
Version/Model Number
1044
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)
Yes
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
K003153,K003153
Product Code
KLE
Product Code Name
Agent, Tooth Bonding, Resin
Public Device Record Key
89ccbb2f-39ca-415d-a142-290cc3130ef0
Public Version Date
June 13, 2019
Public Version Number
1
DI Record Publish Date
June 05, 2019
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 | 40 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 396 |
| U | Unclassified | 5 |