Duns Number:688322841
Device Description: Meta P&Bond is a wet bond adhesive system that is activated by visible light curing. This Meta P&Bond is a wet bond adhesive system that is activated by visible light curing. This bonding agent is one-step for priming and bonding. It is formulated to adhesively bond to hard surfaces of the oral cavity, namely enamel and dentin, for use with dental cements like Metacem.
Catalog Number
-
Brand Name
Meta P&Bond
Version/Model Number
9221
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
August 29, 2018
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)
-
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
K081913
Product Code
EMA
Product Code Name
Cement, Dental
Public Device Record Key
b2cb5028-9ec3-459a-9cc4-fea48f455785
Public Version Date
January 24, 2022
Public Version Number
4
DI Record Publish Date
September 19, 2016
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 | 1335 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 284 |