Duns Number:124763728
Device Description: Noble. Type III Good tarnish resistance with only 46% gold content. A moderately priced go Noble. Type III Good tarnish resistance with only 46% gold content. A moderately priced gold content alloy. You will find it to be your workhorse for crown and bridge alloy needs. With an excellent track record in terms of tarnish resistance, it can be used in all but the most reactive mouth situation.
Catalog Number
-
Brand Name
Apollo Type lll Yellow Crown & Bridge Alloy
Version/Model Number
1124525
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
K020949
Product Code
EJT
Product Code Name
Alloy, Gold-Based Noble Metal
Public Device Record Key
9b358a64-0edd-4422-8432-4b05457ec8e2
Public Version Date
July 09, 2020
Public Version Number
5
DI Record Publish Date
February 16, 2017
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 | 16 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 1346 |