The following data is part of a premarket notification filed by Silfradent S.r.l. with the FDA for Surgybone.
| Device ID | K083569 |
| 510k Number | K083569 |
| Device Name: | SURGYBONE |
| Classification | Drill, Bone, Powered |
| Applicant | SILFRADENT S.R.L. 110 E. GRANADA BLVD., STE. 207 Ormond Beach, FL 32176 |
| Contact | Claude D Berthoin |
| Correspondent | Claude D Berthoin SILFRADENT S.R.L. 110 E. GRANADA BLVD., STE. 207 Ormond Beach, FL 32176 |
| Product Code | DZI |
| CFR Regulation Number | 872.4120 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Abbreviated |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2008-12-03 |
| Decision Date | 2009-04-01 |
| Summary: | summary |