Duns Number:595078345
Device Description: Package contains an OVC Lithium for tooth number FDI 14.15 : USA 4-5 in shade A1 and size Package contains an OVC Lithium for tooth number FDI 14.15 : USA 4-5 in shade A1 and size L (large), 4 x OVC Wedges, 1 x Selector Key, 1 x OVC Matrix Band and 1 x OVC Lithium Replica.
Catalog Number
81443161120
Brand Name
OVC Lithium
Version/Model Number
OVC Lithium FDI 14.15 L : USA 4-5 L A1
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
December 05, 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
-
Product Code
EIH
Product Code Name
Powder, Porcelain
Public Device Record Key
6d5b3878-83bf-4ad8-936a-489e28c2364a
Public Version Date
August 15, 2018
Public Version Number
4
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 |