Duns Number:595078345
Device Description: The Professional Kit consists of 40 OVC Lithium in tooth shade A2 - for Upper and Lower mo The Professional Kit consists of 40 OVC Lithium in tooth shade A2 - for Upper and Lower molars and premolars. Each OVC Lithium is packaged with 2 x OVC Wedges, 2 x Stretch Wedges, a Selector Key, 1 x OVC3 Matrix Band and an OVC Lithium Replica.
Catalog Number
9421031795320
Brand Name
OVC3 Lithium
Version/Model Number
Professional Kit A2
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
913a6f48-a1d6-4783-bcb1-9c1784a6a9ce
Public Version Date
September 04, 2018
Public Version Number
4
DI Record Publish Date
October 03, 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 |