Duns Number:044668515
Device Description: COSMETIC SL EMPOWER CLEAR PASSIVE UL BICUSPID 022 T-7 A=0 R=0 W/HK DIST
Catalog Number
1585-22-2407HD
Brand Name
Empower Clear
Version/Model Number
1585-22-2407HD
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
March 18, 2020
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
-
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
K122753
Product Code
NJM
Product Code Name
Bracket, ceramic, orthodontic
Public Device Record Key
63898b58-0f8f-40d7-8594-9b850ae4ef07
Public Version Date
March 19, 2020
Public Version Number
5
DI Record Publish Date
December 20, 2016
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 | 16634 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 982 |