Duns Number:595078345
Device Description: Package contains an OVC for tooth number 18 or 19, in shade A2 and size M (medium), 4 x OV Package contains an OVC for tooth number 18 or 19, in shade A2 and size M (medium), 4 x OVC wedges, a selector key and an OVC Replica
Catalog Number
-
Brand Name
OVC™ One Visit Crown
Version/Model Number
OVC 18-19 M A2
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
September 01, 2017
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
e038a50f-c87d-431d-8d39-55939f5c296f
Public Version Date
November 26, 2018
Public Version Number
4
DI Record Publish Date
September 24, 2016
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 |