Duns Number:595078345
Device Description: The Introduction Kit consists of a set of 10 OVC Hybrid in tooth shade A3 - one each of OV The Introduction Kit consists of a set of 10 OVC Hybrid in tooth shade A3 - one each of OVC Hybrid 4-5 S, M, 12-13 S, M, 18-19 S, M, L, 30-31 S, M, L. Each OVC Hybrid is packaged with 4 x OVC Wedges, a Selector Key, OVC Matrix Band and an OVC Hybrid Replica.
Catalog Number
81021101011
Brand Name
OVC Hybrid
Version/Model Number
Introduction Lite Kit A3
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
October 31, 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
30fec541-bad2-497d-8df7-103b322fd843
Public Version Date
August 29, 2018
Public Version Number
4
DI Record Publish Date
September 14, 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 |