Duns Number:595078345
Device Description: The Introduction Kit consists of a set of 16 OVC Hybrid in tooth shade A3 - one each of O The Introduction Kit consists of a set of 16 OVC Hybrid in tooth shade A3 - one each of OVC Hybrid 4-5 S, M, 12-13 S, M, and two each of 18-19 S, M, L, 30-31 S, M, L. Each OVC Hybrid is packaged with a selector key, 2 x OVC Wedges, 2 x Stretch Wedges, a OVC3 Matrix Band and an OVC Replica.
Catalog Number
9421031795368
Brand Name
OVC3 Hybrid
Version/Model Number
Introduction Kit A3
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
January 22, 2018
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
EBF
Product Code Name
Material, Tooth Shade, Resin
Public Device Record Key
f84b9d43-b1bf-4225-834a-a3b137c929af
Public Version Date
November 26, 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 |