Duns Number:008256356
Device Description: Unitek(TM) Gemini Clear Ceramic Bracket APC(TM) II MBT(TM) U/L 3x3 3Hk .018 Kt
Catalog Number
3117-105
Brand Name
APC™ II Unitek™ Gemini Clear
Version/Model Number
3117-105
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
K944286
Product Code
DYW
Product Code Name
BRACKET, PLASTIC, ORTHODONTIC
Public Device Record Key
ad28c51e-0a4c-4a90-aee5-380d1305feb5
Public Version Date
July 06, 2018
Public Version Number
3
DI Record Publish Date
August 04, 2017
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 | 30 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 610 |