Duns Number:595078345
Device Description: Packages contain x 6 matrix bands for upper molars 16.17 S (small), 16.17 M (medium), 16.1 Packages contain x 6 matrix bands for upper molars 16.17 S (small), 16.17 M (medium), 16.17 L (large), 26.27 S (small), 26.27 M (medium), 26.27 L (large), x 6 matrix bands for lower molars 36.37 S (small), 36.37 M (medium), 36.37 L (large), 46.47 S (small), 46.47 M (medium), 46.47 L (large), x 16 stretch wedges
Catalog Number
9421031795580
Brand Name
OVC3 One Visit Crown
Version/Model Number
OVC3 McDonald Matrix Band - Premolar Accessories Pack
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
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)
-
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
DZN
Product Code Name
Instruments, Dental Hand
Public Device Record Key
f69ade7c-00de-4c52-aa99-0aaa11352dac
Public Version Date
March 14, 2019
Public Version Number
2
DI Record Publish Date
November 28, 2018
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 |