Duns Number:148312838
Device Description: ALPHA-DENT® Light Cure Pit & Fissure Sealant is a hard-setting, wear resistent, un-filled ALPHA-DENT® Light Cure Pit & Fissure Sealant is a hard-setting, wear resistent, un-filled resin based material that has ideal flowable viscosity for maximum coverage and protection to seal pits and fissures of teeth susceptible to caries. Kit Contains: 2 x 3ml Sealant (Opaque White), 2 x 4g Etch Gel Syringes, Dispensing Pad
Catalog Number
401.0003.001
Brand Name
ALPHA-DENT® Light Cure Pit & Fissure Sealant
Version/Model Number
401.0003.001
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
K924635
Product Code
EBC
Product Code Name
Sealant, Pit And Fissure, And Conditioner
Public Device Record Key
0ebb2759-c525-47da-80eb-06b59f28c6be
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 |