Duns Number:607859147
Device Description: Disposable tray with pre-inserted thermoplastic bite wafer used for dental impressions in Disposable tray with pre-inserted thermoplastic bite wafer used for dental impressions in conjunction with final impression materials.
Catalog Number
-
Brand Name
ThermTray1 Quadrant UR-LL
Version/Model Number
114
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
EHY
Product Code Name
Tray, Impression, Preformed
Public Device Record Key
aa9c8390-c99e-4e5f-aed1-96f91f75174b
Public Version Date
March 29, 2018
Public Version Number
2
DI Record Publish Date
November 04, 2016
Package DI Number
10859787002076
Quantity per Package
10
Contains DI Package
00859787002079
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Box
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 2 | A medical device with a moderate to high risk that requires special controls. | 4 |