Duns Number:279456896
Device Description: IM3P surgery tip compatible MectronHYGITECHReference: HY-98034Surgery tip with marking and IM3P surgery tip compatible MectronHYGITECHReference: HY-98034Surgery tip with marking and double irrigation (to avoid overheating in the maxilla). Necessary for the preparation of the implant site and in particular for bone perforation. Used in two concrete clinical applications:• For implant site expansion • To complete the preparation of the implant bedDiameter: 3 mm
Catalog Number
HY-98034
Brand Name
HYGITECH
Version/Model Number
HY-98034
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"
Yes
For Single-Use
-
Prescription Use (Rx)
-
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
EJB
Product Code Name
Handle, Instrument, Dental
Public Device Record Key
ade23294-72e8-4d53-afa6-b03f827a796a
Public Version Date
December 24, 2020
Public Version Number
1
DI Record Publish Date
December 16, 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 | 87 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 8 |