Duns Number:801157132
Device Description: Ideal Clear 030 120MM Circle Erko
Catalog Number
IS25-110-31
Brand Name
Ideal Clear
Version/Model Number
IS25-110-31
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
February 19, 2021
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"
Yes
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
K062828,K062828
Product Code
EBG
Product Code Name
CROWN AND BRIDGE, TEMPORARY, RESIN
Public Device Record Key
624970c9-275f-4cc9-a8d1-62e9f969b8d3
Public Version Date
September 23, 2021
Public Version Number
6
DI Record Publish Date
September 24, 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 | 66 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 103 |
| U | Unclassified | 13 |