Duns Number:830016148
Device Description: 3M™ Filtek™ Matrix Upper Anterior, 3-4 Units, 749-134, 1 matrix/ plastic bag
Catalog Number
749-134
Brand Name
3M™ Filtek™
Version/Model Number
749-134
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
EHY
Product Code Name
TRAY, IMPRESSION, PREFORMED
Public Device Record Key
64588c8c-539e-4344-bfbe-08d2c945cdf5
Public Version Date
November 01, 2021
Public Version Number
1
DI Record Publish Date
October 22, 2021
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 | 274 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 444 |
| U | Unclassified | 7 |