Duns Number:044668515
Device Description: COSMETIC SL EMPOWER CLEAR INTERACT UL CUSPID 022 T=0 A+8 R=0 W/HK DIST
Catalog Number
1485-22-230HD
Brand Name
Empower Clear
Version/Model Number
1485-22-230HD
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
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
ca27db05-a373-4b73-8ce1-9a53d44ff52b
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 |