Duns Number:044668515
Device Description: COSMETIC SL EMPOWER CLEAR PASSIVE UR CUSPID 022 T=0 A+8 R=0 W/HK DIST
Catalog Number
1585-22-130HD
Brand Name
Empower Clear
Version/Model Number
1585-22-130HD
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
K122753
Product Code
NJM
Product Code Name
Bracket, Ceramic, Orthodontic
Public Device Record Key
626bd018-cbff-4085-acb0-5a2bf1b20bcb
Public Version Date
June 22, 2020
Public Version Number
2
DI Record Publish Date
March 12, 2020
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 |