Duns Number:320744915
Device Description: DeltaFil is a radiopaque, classic glass ionomer restorative material in capsule form. Delt DeltaFil is a radiopaque, classic glass ionomer restorative material in capsule form. DeltaFilchemically bonds to enamel and dentine and releases fluoride ions. It is available in the shadesA1, A2, A3 and A4 based on the Vita color system and White and Dark. Each capsule contains a minimumusable amount of 0.13 ml.DeltaFil Conditioner is an aqueous polyacrylic acid solution for treating the smear layerfollowing preparation and for conditioning the cavity, which optimizes the bonding of DeltaFilto the tooth’s structure.DeltaFil50 Applicap @ 370 mg powder, 75 mg liquid (0.07 ml), Shade A2
Catalog Number
540001
Brand Name
DeltaFil
Version/Model Number
540001
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
-
Product Code
EMA
Product Code Name
Cement, Dental
Public Device Record Key
220890a8-4b81-4aa7-84c6-fee46451ce53
Public Version Date
October 26, 2022
Public Version Number
3
DI Record Publish Date
June 13, 2022
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 | 24 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 143 |