Duns Number:006385173
Device Description: A strip or sheet of suitable material coated with pigment and used for marking areas of co A strip or sheet of suitable material coated with pigment and used for marking areas of contact between opposite teeth, restorations or appliances. This is a single-use device.
Catalog Number
60203
Brand Name
Articulating paper/film
Version/Model Number
60203
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
February 18, 2022
Issuing Agency
In HIBCC
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
58e16f1f-c1d9-41e4-b6ce-6546f6ad1e1d
Public Version Date
February 21, 2022
Public Version Number
2
DI Record Publish Date
August 24, 2020
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 | 63 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 293 |
| U | Unclassified | 1 |