Duns Number:279456896
Device Description: SL2 surgery tip compatible SatelecHYGITECHReference: HY-98113Diamond ball tip (1.5m), with SL2 surgery tip compatible SatelecHYGITECHReference: HY-98113Diamond ball tip (1.5m), with laser marking every 2mm. Recommended for:• Smoothing of the edges of the vestibular bone flap • Precision OsteoplastyCompatible with : Piezotome, Implant Center™
Catalog Number
HY-98113
Brand Name
HYGITECH
Version/Model Number
HY-98113
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
ef8a897f-adb0-4ae1-a29e-8235f0c8452d
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 |