Duns Number:480420090
Device Description: Matrix bands Type 8 matrix bands are stainless steel anatomically preformed bands used in 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°7
Catalog Number
-
Brand Name
MATRIX BANDS TYPE 8 X-THIN N.7
Version/Model Number
41762
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
June 30, 2022
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
2e4c3e18-1717-48e2-a645-2aca30362f2e
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 |