Duns Number:487506230
Device Description: Pekkton ivory Press BlankPekkton® ivory – press ingots / 10 p.
Catalog Number
01060003
Brand Name
Pekkton ivory
Version/Model Number
01060003
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
EBF
Product Code Name
Material, Tooth Shade, Resin
Public Device Record Key
104d0864-39dd-4f22-a430-1407dcee6aea
Public Version Date
September 24, 2021
Public Version Number
8
DI Record Publish Date
April 25, 2016
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 | 208 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 535 |