Duns Number:595078345
Device Description: Package contains an OVC for tooth number FDI 34.35 USA 20-21, in shade A1, and size XL (ex Package contains an OVC for tooth number FDI 34.35 USA 20-21, in shade A1, and size XL (extra-large), 4 x OVC wedges, 1 x Selector key, 1 x OVC replica and 1 x OVC Matrix Band.
Catalog Number
83453181120
Brand Name
OVC Lithium
Version/Model Number
OVC Lithium FDI 34.35 XL : USA 20-21 XL 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
2109c807-40ee-4fad-9a8f-411d0901b3f3
Public Version Date
August 15, 2018
Public Version Number
4
DI Record Publish Date
September 21, 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 |