The following data is part of a premarket notification filed by Salvin Dental Specialties, Inc. with the FDA for Salvin Dental Specialties Fixation Screw.
| Device ID | K100182 |
| 510k Number | K100182 |
| Device Name: | SALVIN DENTAL SPECIALTIES FIXATION SCREW |
| Classification | Screw, Fixation, Intraosseous |
| Applicant | SALVIN DENTAL SPECIALTIES, INC. 3450 LATROBE DR. Charlotte, NC 28211 |
| Contact | Robert Salvin |
| Correspondent | Robert Salvin SALVIN DENTAL SPECIALTIES, INC. 3450 LATROBE DR. Charlotte, NC 28211 |
| Product Code | DZL |
| CFR Regulation Number | 872.4880 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2010-01-21 |
| Decision Date | 2010-05-10 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00841336100015 | K100182 | 000 |