Duns Number:480420090
Device Description: Universal Dental - White Normal Quality - 6 sticksUniversal Solder can be used to braze ma Universal Dental - White Normal Quality - 6 sticksUniversal Solder can be used to braze many metals or alloys to another metal or alloy as long as their melting points are not lower than 600 CIt is intended for orthodontics, temporary appliances, repairs
Catalog Number
-
Brand Name
Universal Solder
Version/Model Number
10002
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
-
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
ECR
Product Code Name
Setter, Band, Orthodontic
Public Device Record Key
57059cc3-2736-4491-bc9e-ce175e8ec31f
Public Version Date
June 23, 2022
Public Version Number
1
DI Record Publish Date
June 15, 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 | 278 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 1 |