Duns Number:144140845
Device Description: DELTON® FS+ FLOWABLE Pit & Fissure Sealant with FLUORIDE Light Curing Opaque. Refill Kit. DELTON® FS+ FLOWABLE Pit & Fissure Sealant with FLUORIDE Light Curing Opaque. Refill Kit. Also contains: Delton® Syringes, EZ Etch Syringe, EZ Tips, and Syringe Sleeves.
Catalog Number
-
Brand Name
DELTON®
Version/Model Number
310201
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
-
Product Code
EBC
Product Code Name
SEALANT, PIT AND FISSURE, AND CONDITIONER
Public Device Record Key
9635afcf-8b0f-4803-9b35-e83481665dca
Public Version Date
March 29, 2018
Public Version Number
2
DI Record Publish Date
September 23, 2016
Package DI Number
D0033102012
Quantity per Package
12
Contains DI Package
D0033102011
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Case
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 13 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 156 |