Duns Number:439064973
Device Description: SURGYBONE, the electromedical equipment by SILFRADENT Srl, is a dental instrument performi SURGYBONE, the electromedical equipment by SILFRADENT Srl, is a dental instrument performing operations in the field of dental piosthesis and endodontics by means of ultrasound vibrations produced by a piezoelectric transducer.
Catalog Number
-
Brand Name
Silfradent S.r.l.
Version/Model Number
SURGYBONE na
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
K083569,K083569
Product Code
DZI
Product Code Name
Drill, Bone, Powered
Public Device Record Key
cf24226f-7a89-4c7a-a7de-78c92712780e
Public Version Date
July 06, 2018
Public Version Number
3
DI Record Publish Date
December 13, 2016
Package DI Number
18056093310013
Quantity per Package
1
Contains DI Package
08056093310016
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Paper Box
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 2 | A medical device with a moderate to high risk that requires special controls. | 45 |