Duns Number:012676012
Device Description: Anterior Dual Arch Impression Tray for Dental UseDisposable, Rigid, Alignment Sticks inclu Anterior Dual Arch Impression Tray for Dental UseDisposable, Rigid, Alignment Sticks included to mark facial Mid-Line40/box
Catalog Number
-
Brand Name
Harmony Anterior Disposable Dual Arch Tray
Version/Model Number
Anterior
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)
-
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
EHY
Product Code Name
Tray, Impression, Preformed
Public Device Record Key
91196e11-3021-4f49-84ca-3a90097bee79
Public Version Date
March 29, 2018
Public Version Number
2
DI Record Publish Date
October 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 | 5 |