Duns Number:008256356
Device Description: APC FF Clarity Ultra SL MBT U Rt Cuspid 0T/8A DHk 022
Catalog Number
4003-308
Brand Name
3M™ Unitek™ APC™ Clarity™ MBT™
Version/Model Number
4003-308
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)
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
4dea08b9-c8da-414b-b0f5-74876ed24155
Public Version Date
February 12, 2019
Public Version Number
2
DI Record Publish Date
October 23, 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 | 30 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 610 |