Duns Number:192699952
Device Description: Accent Ceramic Orthodontic Bracket MBT 022 Lo 4 UNI Hk
Catalog Number
-
Brand Name
ACCENT
Version/Model Number
A0668H
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
K052245
Product Code
NJM
Product Code Name
Bracket, Ceramic, Orthodontic
Public Device Record Key
ddc6f041-dcdf-47c2-a88a-37ab94a5e647
Public Version Date
September 17, 2018
Public Version Number
1
DI Record Publish Date
August 17, 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 | 1 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 222 |