Duns Number:096010525
Device Description: Self-Cured Resin for Sealing Occusal Fissures and Bonding Composite Restoratives to Etched Self-Cured Resin for Sealing Occusal Fissures and Bonding Composite Restoratives to Etched Enamel. Italian.
Catalog Number
50-12
Brand Name
International Dental Supply Pit & Fissure Sealer Bonding Agent
Version/Model Number
ID 50-12
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
Yes
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
K850675
Product Code
EBD
Product Code Name
Coating, Filling Material, Resin
Public Device Record Key
ac3958a3-ad92-49fa-88f5-4b772ef8d5f6
Public Version Date
July 06, 2018
Public Version Number
3
DI Record Publish Date
August 11, 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 | 10 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 476 |