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 |
00841336120884 | K073342 | 000 |
00841336120877 | K073342 | 000 |
00841336120785 | K073342 | 000 |
00841336112322 | K073342 | 000 |
00841336110083 | K073342 | 000 |
00841336109834 | K073342 | 000 |
00841336109827 | K073342 | 000 |
00841336109803 | K073342 | 000 |
00841336109766 | K073342 | 000 |
00841336109759 | K073342 | 000 |
00841336109742 | K073342 | 000 |
00841336120891 | K073342 | 000 |
00841336100039 | K073342 | 000 |
00841336100046 | K073342 | 000 |
00841336100152 | K073342 | 000 |
00841336100145 | K073342 | 000 |
00841336100138 | K073342 | 000 |
00841336100121 | K073342 | 000 |
00841336100114 | K073342 | 000 |
00841336100107 | K073342 | 000 |
00841336100091 | K073342 | 000 |
00841336100084 | K073342 | 000 |
00841336100077 | K073342 | 000 |
00841336100060 | K073342 | 000 |
00841336100053 | K073342 | 000 |
00841336109698 | K073342 | 000 |