Duns Number:053529939
Catalog Number
F-6302
Brand Name
Ortho Bracket Paste LC 5g Syr
Version/Model Number
F-6302
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
April 03, 2019
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
DYH
Product Code Name
ADHESIVE, BRACKET AND TOOTH CONDITIONER, RESIN
Public Device Record Key
33c36649-f54b-4c07-9871-e1959a2e2b8e
Public Version Date
April 04, 2019
Public Version Number
3
DI Record Publish Date
June 12, 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 | 335 |
2 | A medical device with a moderate to high risk that requires special controls. | 675 |