Duns Number:595078345
Device Description: The Introduction Lite Kit consists of a set of 10 OVC Hybrid in tooth shade A3 - one each The Introduction Lite 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 a selector key, 2 x OVC Wedges, 2 x Stretch Wedges, a OVC3 Matrix Band and an OVC Replica.
Catalog Number
9421031795276
Brand Name
OVC3 Hybrid
Version/Model Number
Introduction Lite Kit A3
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
January 25, 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
EIH
Product Code Name
Powder, Porcelain
Public Device Record Key
319a309f-bacf-411f-98d8-5c9bc404a6ff
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 |