The following data is part of a premarket notification filed by Salvin Dental Specialties with the FDA for Salvin Tenting Screw System.
| Device ID | K161857 |
| 510k Number | K161857 |
| Device Name: | Salvin Tenting Screw System |
| Classification | Screw, Fixation, Intraosseous |
| Applicant | Salvin Dental Specialties 3450 Latrobe Drive Charlotte, NC 28211 |
| Contact | Jennifer Singer |
| Correspondent | John Kapitan KAPSTONE MEDICAL, LLC PO BOX 969 Leicester, NC 28748 |
| Product Code | DZL |
| CFR Regulation Number | 872.4880 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2016-07-06 |
| Decision Date | 2017-04-28 |
| Summary: | summary |