Duns Number:688282516
Device Description: DENTA II body(DENTA II laser system)
Catalog Number
-
Brand Name
DENTA II
Version/Model Number
DENTA II body
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
-
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
K091320,K091320
Product Code
GEX
Product Code Name
Powered Laser Surgical Instrument
Public Device Record Key
138d329d-7dd4-43d2-986c-83d925d9c642
Public Version Date
July 06, 2018
Public Version Number
3
DI Record Publish Date
September 13, 2016
Package DI Number
8809447651514
Quantity per Package
1
Contains DI Package
08809447651507
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
carton case
Device Class | Device Class Description | No of Devices |
---|---|---|
2 | A medical device with a moderate to high risk that requires special controls. | 145 |