Duns Number:151289394
Device Description: Blue Permaband Composite Light Cure Band Cement 7gm Syr
Catalog Number
-
Brand Name
ORTHOSOURCE
Version/Model Number
557-607
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)
Yes
Device labeled as "Not made with natural rubber latex"
-
For Single-Use
-
Prescription Use (Rx)
-
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
K861258
Product Code
DYH
Product Code Name
Adhesive, Bracket And Tooth Conditioner, Resin
Public Device Record Key
bd622f87-e164-4227-8e94-ca2ce7d2b6e6
Public Version Date
November 28, 2019
Public Version Number
1
DI Record Publish Date
November 20, 2019
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 | 174 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 96 |