Duns Number:595078345
Device Description: The SML Kit consists of a set of 24 OVCs in tooth shade A2 - one each for 8 tooth types, u The SML Kit consists of a set of 24 OVCs in tooth shade A2 - one each for 8 tooth types, upper and lower molar and premolars, in three sizes for each tooth type individually packaged. Each OVC Hybrid is packaged with 2 x OVC Wedges, 2 x Stretch Wedges, a Selector Key, 1 x OVC3 Matrix Band and an OVC Hybrid Replica.
Catalog Number
9421031792046
Brand Name
OVC3 Hybrid
Version/Model Number
SML Kit A2
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
May 16, 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
901d0cd6-1539-45ab-a529-6372c7c6359e
Public Version Date
August 29, 2018
Public Version Number
4
DI Record Publish Date
December 05, 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 |