The following data is part of a premarket notification filed by Salvin Dental Specialties, Inc. with the FDA for Salvin Dental Specialties, Inc., Fixation Screw.
| Device ID | K073342 |
| 510k Number | K073342 |
| Device Name: | SALVIN DENTAL SPECIALTIES, INC., 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 | 2007-11-28 |
| Decision Date | 2008-03-26 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00841336100169 | K073342 | 000 |
| 00841336100046 | K073342 | 000 |
| 00841336100053 | K073342 | 000 |
| 00841336100060 | K073342 | 000 |
| 00841336100077 | K073342 | 000 |
| 00841336100084 | K073342 | 000 |
| 00841336100091 | K073342 | 000 |
| 00841336100107 | K073342 | 000 |
| 00841336100114 | K073342 | 000 |
| 00841336100121 | K073342 | 000 |
| 00841336100138 | K073342 | 000 |
| 00841336100145 | K073342 | 000 |
| 00841336100152 | K073342 | 000 |
| 00841336100039 | K073342 | 000 |