Duns Number:688322841
Device Description: Dental composite resin is a device intended to restore carious lesions or structural defec Dental composite resin is a device intended to restore carious lesions or structural defects in teeth.Ezfil is indicated for Class 1, 2, 3, 4, 5 restorations, Core-buildup to replace missing tooth structure, Diastema closures, Direct veneers, Composite and porcelain repairs.The color is 18 colors with A1, A2, A3, A3.5, A4, B1, B2, B3, B4, C1, C2, C3, C4, D2, D3, D4, OP and TL.
Catalog Number
-
Brand Name
Ezfil TL
Version/Model Number
9433
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In GS1
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
K191991
Product Code
EBF
Product Code Name
Material, Tooth Shade, Resin
Public Device Record Key
b96a1599-b4db-41ce-835d-73198a14d094
Public Version Date
March 23, 2020
Public Version Number
1
DI Record Publish Date
March 15, 2020
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 | 1335 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 284 |