Duns Number:595078345
Device Description: The Professional Kit consists of 40 OVC Lithium in tooth shade A3 - for Upper and Lower mo The Professional Kit consists of 40 OVC Lithium in tooth shade A3 - for Upper and Lower molars and premolars. Each OVC Lithium is packaged with 4 x OVC Wedges, a Selector Key, 1 OVC Matrix Band and an OVC Lithium Replica. Each kit has spare Matrix Bands.
Catalog Number
81101101020
Brand Name
OVC Lithium
Version/Model Number
Professional Kit A3
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
265a8905-4e6e-471e-b3a3-8fa0104c67c5
Public Version Date
August 15, 2018
Public Version Number
4
DI Record Publish Date
April 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 |