Duns Number:480420090
Device Description: Transparent strips are matrices which help contour restorative materials to match natural Transparent strips are matrices which help contour restorative materials to match natural dentition (generally light-cured composite on anterior tooth). Transparent strips are made of Biaxially-oriented Polyethylene terephthalate (Bo-PET) films.The products are used in the dentistry field. Pack of 50
Catalog Number
-
Brand Name
TRANSPARENT ODUS UNIVERSAL STRIPS CURVED, 6 mm
Version/Model Number
43711d
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)
Yes
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
EHM
Product Code Name
Strip, Polishing Agent
Public Device Record Key
9c8b8bf6-d142-41c7-800f-2833722f4a7d
Public Version Date
July 06, 2022
Public Version Number
1
DI Record Publish Date
June 28, 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 |