Duns Number:551746187
Device Description: Porcelain restorations are full porcelain crown and bridge restorations that are manufactu Porcelain restorations are full porcelain crown and bridge restorations that are manufactured as finished products from porcelains.
Catalog Number
-
Brand Name
Restoration
Version/Model Number
005
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
NSP
Product Code Name
Restoration, Porcelain
Public Device Record Key
79055cf0-0330-44e9-8645-e86c3c2e03ed
Public Version Date
March 10, 2021
Public Version Number
3
DI Record Publish Date
July 21, 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 | 9 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 24 |