Duns Number:721541530
Device Description: Pure PMMA Discs are polymenthyl methacrylate blanks used to mill dental long-term temporar Pure PMMA Discs are polymenthyl methacrylate blanks used to mill dental long-term temporary crowns and bridges in various CAD/CAM systems until permanent restorations can be delivered. Restorations are designed and manufactured by dental professionals and technicians using open CAD/CAM technology.
Catalog Number
481
Brand Name
Pure PMMA Disc
Version/Model Number
Shade: MLB1, Thickness: 25mm
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
K172281
Product Code
EBG
Product Code Name
Crown And Bridge, Temporary, Resin
Public Device Record Key
ebb926ec-03d2-42c6-a69d-bf021130567e
Public Version Date
October 29, 2021
Public Version Number
2
DI Record Publish Date
June 30, 2021
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 |
|---|---|---|
| 2 | A medical device with a moderate to high risk that requires special controls. | 511 |