Duns Number:119193803
Device Description: Paraband Tofflemire Matrix Bands save time and improve the quality of restorations with th Paraband Tofflemire Matrix Bands save time and improve the quality of restorations with their more conical formation.Direct Class II composites are simpler and faster to set up, often with no wedges or separating springs required. Restore teeth in a neutral, stable position with predictable broad and deep contacts. Large MODs will become routine.For direct Class III, IV and V composites, the band provides better isolation of the prep, as well as a stable matrix for condensing composite. Bonding to subgingival preparations is simpler due to the isolation and access provided. Works with any Tofflemire retainer. Precision-cut 0.0015" thin stainless steel.
Catalog Number
71-28310
Brand Name
Paraband Tofflemire Matrix Bands
Version/Model Number
7128310
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
Yes
Prescription Use (Rx)
-
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
JEP
Product Code Name
Retainer, Matrix
Public Device Record Key
1704d9c8-dc04-4498-ab62-f4e93bde5876
Public Version Date
August 20, 2018
Public Version Number
1
DI Record Publish Date
July 19, 2018
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 | 93 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 2 |