Duns Number:595078345
Device Description: Package contains an OVC Hybrid in Shade A3 for tooth number FDI 34.35 XL : USA 20-21 XL A3 Package contains an OVC Hybrid in Shade A3 for tooth number FDI 34.35 XL : USA 20-21 XL A3 (Extra-Large) 2 x OVC Wedges, 2 x Stretch Wedges, 1 x Selector Key, 2 x OVC3 Matrix Band and 1 x OVC Replica
Catalog Number
9421031796488
Brand Name
OVC3 Hybrid
Version/Model Number
OVC3 Hybrid FDI 34.35 XL : USA 20-21 XL A3
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
K143694
Product Code
EBF
Product Code Name
Material, Tooth Shade, Resin
Public Device Record Key
9792fe87-5b5b-4818-a563-9596e6d64dfe
Public Version Date
March 21, 2019
Public Version Number
1
DI Record Publish Date
March 13, 2019
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 |