Duns Number:148312838
Device Description: ALPHA-DENT® Porcelain Conditioner permits bonding versatility with patients that have brid ALPHA-DENT® Porcelain Conditioner permits bonding versatility with patients that have bridgework or crowns. This conditioner is a silane coupling agent, which helps to chemically bond the adhesive to porcelain.
Catalog Number
542.0101.001
Brand Name
ALPHA-DENT® Porcelain Conditioner
Version/Model Number
542.0101.001
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
K921044
Product Code
DYH
Product Code Name
Adhesive, Bracket And Tooth Conditioner, Resin
Public Device Record Key
eabe250f-7d27-4858-962f-7cb32a8a7efe
Public Version Date
July 06, 2018
Public Version Number
3
DI Record Publish Date
September 23, 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 |
|---|---|---|
| 2 | A medical device with a moderate to high risk that requires special controls. | 183 |