Duns Number:480420090
Device Description: Articulating Papers are occlusal marking papers, whose aim is to highlight occlusion conta Articulating Papers are occlusal marking papers, whose aim is to highlight occlusion contacts, by creating a mark on the corresponding teeth surfaces (ink transfer). The products are used in the dentistry field. Pack of 12x12 sheets
Catalog Number
-
Brand Name
ARTICULATING PAPER STRAIGHT, BLUE/RED, THIN
Version/Model Number
36405
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
EFH
Product Code Name
Paper, Articulation
Public Device Record Key
d46573d8-f8a4-4acc-a279-c33ded272dd1
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 |