Duns Number:113170088
Device Description: OVS is intended for use as a composite system for the fabrication of veneers on undersized OVS is intended for use as a composite system for the fabrication of veneers on undersized teeth.The kit contains 1 X 3cc Light Bond Sealant, 1 X 2.5g Ortho Veneer paste shade B-1, 1 X 2.5g Ortho Veneer shade A-1, 1 X 2.5g Ortho Veneer shade A-2, (5 Medium and 5 Large) Faci Forms Crown Form #12, (5 Medium and 5 Large) Faci Forms Crown Form #22, 1 X (16) Stick and Place instruments
Catalog Number
OVS
Brand Name
Ortho Veneer System
Version/Model Number
OVS
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In HIBCC
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
-
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
cb484a44-ebd5-4208-8022-a84f2e0e1ee1
Public Version Date
July 24, 2020
Public Version Number
5
DI Record Publish Date
August 17, 2016
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 | 73 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 279 |