Duns Number:480420090
Device Description: Tofflemire matrix bands Type 8 matrix bands are stainless steel anatomically preformed ban Tofflemire matrix bands Type 8 matrix bands are stainless steel anatomically preformed bands used in combination with matrix retainers as part of contouring for restorative treatment. It enables to perform restoration with anatomic proximal contours and contact areas, by creating a temporary interproximal surface (contour). The different matrix bands provided by Produits Dentaires differ in geometry and size. All references exist in 2 different thickness: thin (0.05mm) and xthin (0.035mm). Tofflemire matrix retainers secure the appropriate matrix band in placeBox of 12 bands - N°15 Adults
Catalog Number
-
Brand Name
TOFFLEMIRE MATRIX BANDS X-THIN N.15
Version/Model Number
41517
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
-
Product Code
DYO
Product Code Name
Band, Material, Orthodontic
Public Device Record Key
6b66fcce-db99-45f5-b219-dc6095dd788a
Public Version Date
July 07, 2022
Public Version Number
1
DI Record Publish Date
June 29, 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 | 278 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 1 |