Duns Number:124763728
Device Description: High Noble Medium gold-palladium-low. Metro solders well and does not exhibit the brittlen High Noble Medium gold-palladium-low. Metro solders well and does not exhibit the brittleness some technicians report in other medium-gold ceramic alloys. The small quantity of silver in Metro adjusts its thermal expansion coefficient to make it much more compatible with higher expansion porcelains than other alloys in its class. Yet, it is less expensive than other alloys in this category.
Catalog Number
-
Brand Name
Metro White Ceramic Alloy
Version/Model Number
1064501
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
March 01, 2018
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
EJT
Product Code Name
Alloy, Gold-Based Noble Metal
Public Device Record Key
c0894068-0592-468e-822c-42f7872f0371
Public Version Date
May 27, 2020
Public Version Number
3
DI Record Publish Date
March 10, 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 |