Duns Number:673251143
Device Description: Resin crown and bridge restorations are crown and bridge restorations that are manufacture Resin crown and bridge restorations are crown and bridge restorations that are manufactured as finished products from resins
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
NSN
Product Code Name
Restoration, Resin, Crown And Bridge
Public Device Record Key
acd6d005-1cc4-4e31-89aa-3a4fd104aa3a
Public Version Date
October 11, 2022
Public Version Number
1
DI Record Publish Date
October 03, 2022
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 | 2 |