Duns Number:487506230
Device Description: 0106 0032 Pekkton® ivory milling blank ø 95/24mm (compatible with Zirkonzahn®)
Catalog Number
01060032
Brand Name
Pekkton Ivory
Version/Model Number
01060032
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
August 14, 2020
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
K170102
Product Code
EBF
Product Code Name
Material, Tooth Shade, Resin
Public Device Record Key
72a5029a-bbea-48db-a133-4b99c82251b5
Public Version Date
June 14, 2021
Public Version Number
4
DI Record Publish Date
July 05, 2018
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 |