Duns Number:595078345
Device Description: Package contains an OVC Hybrid in shade A2 for tooth number FDI 44.45 XL : USA 28-29 XL (E Package contains an OVC Hybrid in shade A2 for tooth number FDI 44.45 XL : USA 28-29 XL (Extra-Large), 2 x OVC Wedges, 2 x Stretch Wedges, 1 x Selector Key, 2 x OVC3 Matrix Band, 1 x Hex Stick and 1 x OVC Replica.
Catalog Number
9421031794309
Brand Name
OVC Hybrid
Version/Model Number
OVC3 Hybrid FDI 44.45 XL : USA 28-29 XL A2
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
March 15, 2019
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
EBF
Product Code Name
Material, Tooth Shade, Resin
Public Device Record Key
846b732e-f8e5-42f1-ac47-20ee59b35954
Public Version Date
March 28, 2019
Public Version Number
5
DI Record Publish Date
September 22, 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 | 4 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 407 |