Duns Number:316074384
Device Description: Max. 1. Molar band Dura-Fit left 33 without seating lug
Catalog Number
-
Brand Name
N.A.
Version/Model Number
2882N0033-005
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)
-
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
ECM
Product Code Name
BAND, PREFORMED, ORTHODONTIC
Public Device Record Key
1f37fa7a-4138-4401-9b7e-b3b750b3142a
Public Version Date
October 08, 2019
Public Version Number
1
DI Record Publish Date
September 30, 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 | 5082 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 941 |